Partnership Archives - Clinical ink Fri, 28 Feb 2025 15:25:19 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.2 https://www.clinicalink.com/wp-content/uploads/2022/03/cropped-Clinical-Ink-Icon-Logo-32x32.png Partnership Archives - Clinical ink 32 32 Clinical ink announces exclusive clinical trial license for the SPUR™ AI-enabled Digital Engagement and Retention Solution https://www.clinicalink.com/exclusive-clinical-trial-license-for-spur/ Tue, 18 Feb 2025 12:55:33 +0000 https://www.clinicalink.com/?p=20180 Industry-leading behavioral science tool SPUR™ is validated to predict adherence and will be offered through the Clinical ink technology platform

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Industry-leading behavioral science tool SPUR™ is validated to predict adherence and will be offered through the Clinical ink technology platform

Winston-Salem, NC – Clinical ink, a global life science technology company, is expanding its patient engagement solutions with the inclusion into its 21 CFR Part 11 platform of the SPURTM behavioral assessment tool and the proprietary d.tells™ smart AI engine. These digital tools were developed by Observia, validated by extensive published literature, and used in over 40,000 patients across 27 therapeutic areas by multiple large pharmaceutical companies.

Protocol compliance and retention are critical factors for the success of clinical trials. Behavior can be predicted and modified by the SPUR™ digital assessment tool which identifies behavioral drivers unique to each patient. This provides supportive information to the patient, as well as measures of non-adherence risk to investigators.  In addition, SPUR™ provides investigators with personalized guidance for each patient, including the communication style and content that will resonate with a specific behavioral phenotype. The benefits encompass optimized engagement and reduced risk of non-adherence, such as reduced drop out from a clinical trial. SPUR™ can be administered either prior to or after consent and then readministered during the trial. 

SPUR™ can be further enhanced with the d.tells™ AI engine.  d.tells™ chooses and distributes the most appropriate content and features from the solution library for each patient’s behavioral profile. It further refines the personalization by adapting the frequency, duration, and tone of the messages and notifications it sends, according to the patient’s sociomedical and behavioral data.

Nicholas Alp, MD PhD, Chief Medical Officer of Clinical ink commented “I am excited to see the value that SPUR™ will bring to improving adherence, retention, and data integrity in clinical trials. Not only does this validated tool help sponsors comply with FDA guidance on lifestyle standardization in certain therapeutic classes such as GLP-1, but it also offers unique insights to investigators, helping them support participant adherence to the protocol. This predicts and reduces the risk of drop out, preserving study power.  I wish SPUR™ had been available during my career as a clinical trialist.”

“I’m thrilled that Clinical ink has decided to incorporate SPUR™ into their offering” says Kevin Dolgin, Head of R&D at Observia. “Clinical ink is one of the most forward-thinking clinical trial service providers and their commitment to bring behavioral science into the world of clinical science is proof of this. I strongly believe that thanks to Clinical ink’s initiative, trials will now be more efficient, more precise, and far more patient centric.  At Observia, we look forward to continuing to support Clinical ink with behavioral science input while we assist our commercial customers post-launch.  I can think of no organization that is better suited than Clinical ink to serve as the bridge between clinical and behavioral science.”

The terms of the transaction were not disclosed.

About Clinical ink

Clinical ink is the global life science company bringing data, technology, and patient-centric research together. Our deep therapeutic-area expertise, coupled with behavioral science, eDC/Direct Data Capture, eCOA, eConsent, telehealth, and digital biomarkers advancement (including the use of Continuous Glucose Monitoring for detection of hypoglycemia), support the next generation of clinical trials and ultimately, the clinical management of patients.

About Observia

Observia is a Paris-based health tech company founded in 2011 and a pioneer in personalized digital solutions, dedicated to the engagement and support of patients suffering from one or more chronic diseases. The company is the inventor of SPURTM, a validated, ground-breaking tool for predicting health behavior. Observia’s expert teams are committed to improving health outcomes through behavior change, for everyone, everywhere. The solutions developed by Observia are deeply rooted in proven behavioral science and new technologies. 

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Clinical ink and Teckro Partner to Enhance Site User Engagement https://www.clinicalink.com/clinical-ink-and-teckro-partner-to-enhance-site-user-engagement/ Wed, 31 May 2023 06:00:36 +0000 https://www.clinicalink.com/?p=17655 Clinical ink is delighted to announce its partnership with Teckro, a trailblazer in site user engagement and clinical trial technology solutions.

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Winston-Salem, NC and Limerick, IrelandClinical ink, a pioneering leader in eSource and complex site data collection, is delighted to announce its partnership with Teckro, a trailblazer in mobile site engagement solutions. The collaboration combines Clinical ink expertise in Direct Data Capture with Teckro’s unique mobile app, driving ease of use for research staff and investigators to significantly improve the clinical trial experience.

Clinical ink has a proven track record of managing complex site data collection. The company has prioritized its study solutions to deliver faster time to market, greater ease of use, and better patient experience. Teckro supports informed decisions at the point of care with an intuitive, native mobile app loved by investigators around the world. Together, Clinical ink and Teckro will propel a new era of engagement and usability for site partners.

Expected to be available to site partners globally, the collaboration yields immediate benefits including:

  • Immediate Execution of Inclusion/Exclusion Review and eConsent Facilitation
    Accelerate the process of obtaining electronic consent, reduce administrative burden, and expedite trial enrollment
     
  • One Native App for All Protocols
    Eliminate the site burden of managing dozens of passwords to different study sponsor portals
     
  • Decentralized Experience for Engaging with Study Experts
    Provide immediate answers at the point of care for investigators and site staff
     
  • Interconnected Digital Protocol and Seamless Transition to Data Collection
    Eliminate the risk of the wrong protocol version being used by sites and streamline data capture
     
  • Streamlined Communication for Enhanced Site-Sponsor Collaboration
    Open new opportunities for sponsors to proactively communicate with sites and create a direct feedback loop

“We are partnering with Teckro to bring about a paradigm shift in site user engagement and ease of use in clinical trials,” says Jonathan Goldman, MD, CEO at Clinical ink. “Combining our expertise in complex site data collection with Teckro’s decision support app sets us up to improve site partners’ user experience, compliance, and study timelines.”

“By collaborating with Clinical ink for complex site data collection, we are shaping a new era of simplicity and efficiency in clinical trials,” adds Gary Hughes, Co-Founder and CEO at Teckro. “We can further empower investigators and research staff to navigate study answers seamlessly, streamline data capture, and facilitate enhanced collaboration between sites and sponsors.”

About Clinical ink

Clinical ink is the global life science company bringing data, technology, and patient-centric research together. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancements, drive the standards for data precision and usher in a new generation of clinical trials.

About Teckro

Teckro is the interconnected digital protocol that delivers immediate answers from study resources and experts anytime, anywhere. A single mobile app for all protocols, Teckro is the go-to resource for informed study decisions to orchestrate better patient care. Available on Apple and Android devices, Teckro is used by thousands of investigators around the world for all phases, any trial setting, and every therapeutic area.

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Clinical ink Relaunches Industry-Leading Partner Program https://www.clinicalink.com/clinical-ink-launches-partner-program/ Mon, 19 Sep 2022 10:05:46 +0000 https://www.clinicalink.com/?p=12278 Will deliver competitive commercial impact via differentiated technological, scientific expertise and operational efficiencies September 19, 2022 — Today Clinical ink, a global life science company, […]

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Will deliver competitive commercial impact via differentiated technological, scientific expertise and operational efficiencies

September 19, 2022 — Today Clinical ink, a global life science company, announces the relaunch and expansion of a unique contract research organization (CRO) partnership program. Dedicated to offering our partners, and therefore our joint sponsor customers, a differentiated study experience, the Clinical ink partnership program is rooted in ensuring optimal study design, optimized functional standards, and the implementation of fit-for-purpose technologies to provide successful, best-in-class patient data collection in clinical trials.

Clinical ink has been a leader in providing patient science and patient data collection solutions to CRO Partner for many years, including the majority of the top 10 CRO service providers in addition to many specialized and mid-sized providers. The relaunch of this formal program represents their commitment to the successful deployment of high-quality data solutions in the market, becoming an extension of the expertise and leadership represented within the CROs themselves.

With hundreds of sponsor relationships and studies deployed, spanning over 85 countries, and a library of over 800+ instruments and assessments, Clinical ink offers CRO partners a trusted, experienced team with which to successfully grow market impact, as well as a robust, end-to-end, patient-centered technology platform. Integral to the Clinical ink partner program is the offering of scientific expertise and support to analyze protocols as well as align comprehensive, compliant, fit-for purpose technology. Moreover, the program offers in-depth training and implementation of technology empowerment to allow for nimble, dynamic clinical study configuration under a subscription license model. 

“We are thrilled to provide this exclusive program to our most valued CRO partners, both current and future,” says Chris Crucitti, Chief Commercial Officer. “Together, we will chart successful growth, powering patient outcomes by providing sponsors not only the most competitive, technologically-advanced eSource, patient data and DCT offering in the market, but also best-in-class operational efficiencies and process optimization to ensure continual, collective advancement.”

About Clinical Ink

Clinical ink is the global life science company that brings data, technology, and patient science together. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancements, drive the industry standard for data precision and usher in a new generation of clinical trials. By harnessing digital data, we power sponsors, CROs, researchers, and patients to recenter decentralized trials and rewrite the clinical development experience

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Oxford Team Adopts Clinical ink’s Remote Monitoring Technology for Leading-Edge Parkinson’s Study https://www.clinicalink.com/oxford-adopts-remote-monitoring-technology-for-parkinsons-study/ Thu, 11 Aug 2022 15:04:06 +0000 https://www.clinicalink.com/?p=10685 Oxford NeuroMetrology Group Successfully Deploys Clinical ink Mobile Platform to Monitor Parkinson’s Patients at Home Horsham, Pa.; August 11, 2022 — Clinical ink, a global […]

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Oxford NeuroMetrology Group Successfully Deploys Clinical ink Mobile Platform to Monitor Parkinson’s Patients at Home

Horsham, Pa.; August 11, 2022 — Clinical ink, a global life science technology company, has partnered with the research team at the NeuroMetrology Lab, part of the Nuffield Department of Clinical Neurosciences at the University of Oxford, to deploy remote technology that captures study participants’ symptoms at home. The QxQUIP Study (Oxford Quantification in Parkinsonism) follows patients over the course of two years and aims to identify measures that can detect Parkinson’s disease progression before the onset of significant symptoms.

This research was initially carried out via in-person clinic visits—conducted four times annually—but with the advent of the pandemic, these visits temporarily halted. A new Sponsor grant enabled the NeuroMetrology Group to include remote or at-home data collection in the study, and work with Clinical ink. By deploying Clinical ink’s sophisticated, sensor and wearable technology and BrainBaseline™ platform, researchers are now able to gather additional data and insight into Parkinson’s disease progression.

“The Covid pandemic was a dark period for many, and yet it accelerated this change in the way this research project is being carried out. The team is now able to gather richer, more nuanced, and accurate data to feed into their analysis.” says Professor Chrystalina Antoniades of the Nuffield Department of Clinical Neurosciences, Head of the NeuroMetrology Group. “The outcomes of this project will improve diagnosis, tracking and treatment of Parkinson’s… [making] clinical trials more efficient, leading to faster drug discovery not only for Parkinson’s, but potentially for a range of neurological conditions.”

Participants in the study are already reporting high satisfaction with the study and the mobile technology, citing that the wearables are “easy to use,” the instructions “clear,” and the exercises “well explained and not at all difficult to accomplish.” This feedback further proves Clinical ink’s commitment to engineering sophisticated, built-for-purpose sensor technology that also offers the best possible user experience. 

Joan Severson, Chief Innovation Officer at Clinical ink, said: “We are honored that our mobile and wearable technology plays an integral role in this study of Parkinson’s disease at Oxford. More, we are excited to collaborate with researchers who tirelessly work to increase objective numerical measures for diagnosing and monitoring disease progression.”

This work follows Clinical ink’s groundbreaking initial findings in the WATCH-PD study, part of the Critical Path Institute’s 3DT and Parkinson’s initiatives, which provides preliminary support for the generation of digital biomarkers associated with Parkinson’s status. 

More information about the Nuffield Department of Clinical Neurosciences at the University of Oxford partnership and the QxQUIP Study can be found here.

About Clinical ink  

Clinical ink is the global life science company that brings data, technology, and patient science together. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancements, drive the industry standard for data precision and usher in a new generation of clinical trials. By harnessing digital data, we power sponsors, CROs, researchers, and patients to recenter decentralized trials and rewrite the clinical development experience.  

About the Nuffield Department of Clinical Neurosciences, University of Oxford   

The Nuffield Department of Clinical Neurosciences (NDCN) aims to carry out high quality research into the function of the nervous system in health and disease. NDCN builds on a long history of research in neurology, brain imaging, eye disorders, and anaesthetics in Oxford which has made major contributions to our understanding of how the brain works and to the development of treatments which have changed lives. 

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Clinical ink Joins SCRS Global Impact Partner Program https://www.clinicalink.com/clinical-ink-joins-scrs-global-impact-partner-program/ Tue, 31 May 2022 19:09:38 +0000 https://www.clinicalink.com/?p=9803 Horsham, PA, May 31, 2022 – Today the Society for Clinical Research Sites (SCRS) announced Clinical ink has joined the organization as a Global Impact […]

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Horsham, PA, May 31, 2022 – Today the Society for Clinical Research Sites (SCRS) announced Clinical ink has joined the organization as a Global Impact Partner (GIP). As a GIP, Clinical ink will participate on the SCRS Global Impact Board at an executive level and work closely with SCRS’ Leadership Council to determine strategic initiatives for SCRS.

Sean Soth, SCRS Senior Vice President of Strategy & Global Business Partnerships shared, “SCRS is proud to welcome Clinical ink to our community. This partnership with SCRS illustrates Clinical ink’s pledge to acknowledge site feedback and develop strong, sustainable sites. SCRS Global Impact partners are accelerating collaboration amongst industry stakeholders and Clinical ink’s valuable expertise will add even more momentum to our mission.”

“We see sites as the lifeblood of clinical development—they currently make and will continue to make clinical research work,” said Lane Nichols, Executive Vice President of Product at Clinical ink. “This partnership gives Clinical ink another opportunity to work alongside research sites to learn and optimize our solutions and processes. Together, we can best serve patient needs and power patient science in clinical research.” 

About Clinical Ink

Clinical ink is the global life science company that brings data, technology, and patient science together. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancements, drive the industry standard for data precision and usher in a new generation of clinical trials. By harnessing digital data, we power sponsors, CROs, researchers, and patients to recenter decentralized trials and rewrite the clinical development experience

About The Society for Clinical Research Sites

Founded in 2012, SCRS is a global organization that unifies the voice of the clinical research site community to create greater site sustainability. Representing over 9,500 sites in 47 countries, SCRS membership provides sites with a community dedicated to advocacy, education, mentorship and connectivity. SCRS is an influential voice for sites and an active partner in industry-wide initiatives and dialogues focused on improving the clinical research enterprise. Our Voice. Our Community. Your Success. Join the community. Visit MySCRS.org.

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Cutting-edge research reveals greater insights into Parkinson’s Disease progression https://www.clinicalink.com/cutting-edge-research-reveals-greater-insights-into-parkinsons-disease-progression/ Fri, 08 Apr 2022 01:14:30 +0000 https://www.clinicalink.com/?p=9588 85% accuracy in early Parkinson’s classification establishes Clinical ink as the industry leader in patient science and digital biomarkers.

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85% accuracy in early Parkinson’s classification establishes Clinical ink as the industry leader in patient science and digital biomarkers

Cutting-edge research reveals greater insights into Parkinson’s Disease progression. 85% accuracy in early Parkinson’s classification establishes Clinical ink as the industry leader in patient science and digital biomarkers.

Horsham, PA, April 4, 2022 — Clinical ink, a global life science technology company, today announces research that strengthens its standing as a critical partner in advancing clinical development for Parkinson’s disease. The WATCH-PD study findings demonstrate the promise of patient-driven mobile assessments and data collection for developing digital biomarkers, showing that these yield greater insights into Parkinson’s disease progression.

Parkinson’s disease is notoriously difficult to quantify, but analysis revealed 85% accuracy in early Parkinson’s classification. The WATCH-PD study deployed in-clinic and at-home wearable assessments. Parkinson’s patients and healthy volunteers completed active assessments via mobile iPhone and corresponding Apple Watch applications designed and developed by Clinical ink. Unique to the Clinical ink solution is the combination of patients’ active and continuous passive data collection, which was processed, monitored, and analyzed on Clinical ink’s BrainBaseline™ platform.

“For over a decade, we have pioneered novel approaches to collecting and connecting patient data,” said Clinical ink Chief Executive Officer Ed Seguine. “Findings from the WATCH-PD study demonstrate that patient-driven technology and patient science will play an integral role in clinical discovery.”

The WATCH-PD study is part of the Critical Path Institute’s 3DT and Parkinson’s initiatives and provides preliminary support for the generation of digital biomarkers associated with Parkinson’s status. Critically, this work demonstrates that more extensive remotely-monitored measures—gathered via mobile technology and wearables—hold the potential to yield greater insights into Parkinson’s disease progression.

Clinical ink Chief Innovation Officer Joan Severson maintains, “These findings demonstrate that the sensitivity and frequency of our measurements provide richer data and greater insights. At the same time, our technology allows us to recruit and engage patients remotely, from anywhere, ensuring better participation and outcomes.”

April is Parkinson’s Awareness Month, a critical time for this announcement, as Clinical ink begins to publish this groundbreaking, collaborative work. Learn more about how we are pioneering patient science via the design and development of fit-for-purpose mobile technologies that integrate into the everyday life of Parkinson’s patients.

About Clinical ink

Clinical ink is the global life science company that brings data, technology, and patient science together. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancements, drive the industry standard for data precision and usher in a new generation of clinical trials. By harnessing digital data, we power sponsors, CROs, researchers, and patients to recenter decentralized trials and rewrite the clinical development experience.

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PPD and Clinical ink Collaborate on Innovative Process for Lupus Assessment and Near Real-Time Access to Endpoint Data https://www.clinicalink.com/ppd-and-clinical-ink-collaborate-on-innovative-process-for-lupus-assessment-and-near-real-time-access-to-endpoint-data/ Mon, 22 Mar 2021 21:09:00 +0000 https://www.clinicalink.com/uncategorized/ppd-and-clinical-ink-collaborate-on-innovative-process-for-lupus-assessment-and-near-real-time-access-to-endpoint-data/ WILMINGTON, N.C. (March 22, 2021) – PPD, Inc. (Nasdaq: PPD), a leading global contract research organization, and Clinical ink, a global clinical technology company, have […]

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WILMINGTON, N.C. (March 22, 2021) – PPD, Inc. (Nasdaq: PPD), a leading global contract research organization, and Clinical ink, a global clinical technology company, have jointly developed a systemic lupus erythematosus (SLE) assessment review process to simplify operationalizing clinical trials for this chronic autoimmune disease. The companies’ collaborative approach focuses on enhancing data quality and research site personnel experiences and efficiencies, in turn supporting pharmaceutical industry clients in developing new SLE treatments.

The foundation of the data collection is a customized PPD version of Clinical ink’s proprietary electronic Lupus Assessment Suite (eLAS®). Using eLAS® simplifies investigator and patient participation in clinical trials and provides pharmaceutical industry customers with near real-time access to SLE endpoint data.

“Combining PPD’s team of SLE operational and clinical experts with Clinical ink’s proprietary eLAS® solution enables us to offer near real-time access to critical SLE endpoint data,” said Carol Olson, M.D., Ph.D., vice president and head of global product development at PPD. “This consolidated approach addresses one of the most important challenges in SLE studies related to the variability of placebo response and improves efficacy signal detection. It also enables us to conduct a central review of key data by a dedicated team, enhancing the accuracy and consistency of our results.”

“The assessments used in SLE clinical trials are complex, subject to wide variability and not routinely used in everyday rheumatology clinical practice,” said Doug Pierce, president of Clinical ink. “These complexities make operationalizing SLE trials incredibly difficult. By bringing together this custom version of eLAS® with PPD’s dedicated expert review team, we are combining efforts to deliver new and enhanced capabilities for customers who are developing new SLE treatment options.”

Clinical ink’s eLAS® is a therapeutic-specific application of its Lunexis™ platform, featuring a fully integrated suite of SLE disease assessment questionnaires and patient-reported outcomes that are completed by clinicians and patients. With eLAS®, investigators enter patient data once and the system automatically populates the appropriate fields across the required assessments, reducing redundant data entries and errors, which saves time and enhances site efficiencies.

Unlike other applications that simply offer stand-alone electronic versions of questionnaires, eLAS® features a fully integrated suite of SLE disease assessment surveys, physical evaluations, tender/swollen joint counts, physician global appraisals and summary forms. The system ensures that adequate, relevant documentation is in place to support the investigator’s findings and disease assessment scoring. The Lunexis platform provides immediate access to data for PPD’s review of trial eligibility prior to enrollment, as well as validation of questionnaire data collected at subsequent visits.

PPD has a dedicated group of experienced professionals with extensive SLE expertise, including board-certified rheumatologists with industry and in-house experience in site personnel training, eligibility confirmation, efficacy data review and safety monitoring. From lab data integration to customized dashboards providing visualization of eLAS® data, PPD’s central review process employs both innovative applications of technology and trained expert medical reviewers who use centralized monitoring techniques as well as traditional data review processes to detect and resolve data issues at the patient, site and study levels to ensure high levels of accuracy and consistency.

About PPD
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our customers include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and more than 26,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help customers bend the cost and time curve of drug development and optimize value in delivering life-changing therapies to improve health.

About Clinical ink
Clinical ink, a global clinical technology company, offers data certainty from source to submission. Our Lunexis™ eSource clinical technology and configurable direct data capture, eCOA, ePRO, and eConsent modules — a suite of solutions for capturing and integrating electronic data from sites, clinicians, and patients at its source — naturally enhance your clinical trial workflow by reducing manual labor, providing anytime, anywhere data access, and saving resources as your trials progress.

PPD Contact
Media:
Randy Buckwalter
+1 919 456 4425
media@ppd.com

Investors:
Tracy Krumme
+1 910 558 4186
investors@ppd.com

This news release contains forward-looking statements. These statements often include words such as “expect,” “believe,” “project,” “forecast,” “estimate,” “target” and other similar expressions. Although we believe these forward-looking statements are based on reasonable assumptions at the time they are made, you should be aware that many factors could affect our actual financial results, and therefore actual results might differ materially from those expressed in the forward-looking statements. Factors that might materially affect such forward-looking statements include, but are not limited to, the fragmented and highly competitive nature of the drug development services industry; changes in trends in the biopharmaceutical industry; our ability to keep pace with rapid technological changes that could make our services less competitive or obsolete; political, economic and/or regulatory influences and changes; and other factors disclosed under the “Risk Factors” section in our periodic reports filed with the Securities and Exchange Commission (SEC), including our latest Annual Report on Form 10-K, which is available on our website at https://investors.ppd.com or the SEC’s website at www.sec.gov. We assume no obligation and disclaim any duty to revise or update any forward-looking statements, or make any new forward-looking statement, whether as a result of new information, future events or otherwise, except as required by applicable law.

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Clinical ink Celebrates 5 Years of Decentralized Trial Experience Company Joins the Decentralized Trials & Research Alliance https://www.clinicalink.com/clinical-ink-celebrates-5-years-of-decentralized-trial-experience/ Wed, 09 Dec 2020 23:20:09 +0000 https://www.clinicalink.com/uncategorized/clinical-ink-celebrates-5-years-of-decentralized-trial-experience/ HORSHAM, Pa.; Dec. 10, 2020 – Clinical ink, a global clinical trial technology company, today announced five years of providing clients with decentralized and hybrid […]

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HORSHAM, Pa.; Dec. 10, 2020 – Clinical ink, a global clinical trial technology company, today announced five years of providing clients with decentralized and hybrid trial solutions. To demonstrate our continued commitment to industry leadership and the movement toward more patient-centric clinical trials, Clinical ink has joined the Decentralized Trials & Research Alliance (DTRA), which enables collaboration of stakeholders to accelerate the adoption of patient-focused, decentralized clinical trials and research within life sciences and healthcare through education and research.

Clinical ink has long been a pioneer of solutions that support decentralized, real-time clinical trial data collection for sites and patients. This year marks the five-year anniversary of two Ebola vaccine studies in which Clinical ink remotely supported 5,000 patients with rapid enrollment and WHO-mandated timelines. Overall, Clinical ink has completed over 300 studies in all phases (I–IV) in 60 countries/70 languages and executed 50+ BYOD studies. Clinical ink is far and away the most experienced eSource provider in the industry.

“Building on our extensive experience in decentralized trials, we transitioned numerous studies that were site-based to home-based during the pandemic,” said Ed Seguine, Clinical ink CEO. “Our direct data capture (DDC) technology is the gold standard for COVID-19 studies because it permits data access and remote monitoring in real time. Our BYOD ePRO experience for patients helps improve compliance and simplify patient participation in clinical trials. Clinical ink is committed to supporting meaningful improvements in clinical trials (#NoGoingBack). In that spirit, we are proud to join the DTRA as we work toward the technological changes our industry and its patients require.”

Clinical ink’s Lunexis™ platform enables remote participation while providing a full suite of mixed modalities: a single platform that allows patients and sites to switch back and forth among phone, tablet, or web, at virtual or physical sites, as desired. Lunexis supports BYOD, eConsent, telehealth/medicine, and more, bringing all data together from remote environments.

“Now is the time to share ideas and insights that will chart the future course of clinical trials, accelerating drug development and saving lives — and by taking part in the DTRA, Clinical ink is demonstrating its leadership to drive change,” said Craig Lipset, DTRA co-convener and clinical innovation advisor. “We have a responsibility to advance the health of people with unmet medical needs, and by convening stakeholders from pharma companies, regulators, technology leaders, and patient communities, we can remove remaining barriers to adoption and impact patients today.”

About Clinical ink
Clinical ink, a global clinical technology company, offers data certainty from source to submission. Our Lunexis™ eSource clinical technology and configurable direct data capture, eCOA, ePRO, and eConsent modules — a suite of solutions for capturing and integrating electronic data from sites, clinicians, and patients at its source — naturally enhance your clinical trial workflow by reducing manual labor, providing anytime, anywhere data access, and saving resources as your trials progress.

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Cogstate and Clinical Ink Deliver Enhanced Tablet-Based eCOA for CNS Clinical Trials https://www.clinicalink.com/cogstate-and-clinical-ink-deliver-enhanced-tablet-based-ecoa-for-cns-clinical-trials/ Wed, 17 Apr 2019 18:18:32 +0000 https://www.clinicalink.com/uncategorized/cogstate-and-clinical-ink-deliver-enhanced-tablet-based-ecoa-for-cns-clinical-trials/ NEW HAVEN, CT & PHILADELPHIA, PA – October 25, 2016 –  Cognitive science company, Cogstate Ltd (ASX.CGS) and Clinical Ink, the leading provider of eSource […]

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NEW HAVEN, CT & PHILADELPHIA, PA – October 25, 2016 –  Cognitive science company, Cogstate Ltd (ASX.CGS) and Clinical Ink, the leading provider of eSource and patient engagement technologies, today announced they have formalized their long-standing relationship with a strategic alliance that delivers enhanced tablet-based neuropsychological assessments for CNS clinical trials. The alliance combines, in a single solution, the scientific and adult learning expertise provided by Cogstate with the market-leading eSource data capture platform from Clinical Ink.

“Our goal is to transform the entire rater experience with process-enabling technologies that lead to better assessments, so a partnership with the eSource pioneers at Clinical Ink was the clear choice for advancing that objective”, commented Cogstate CEO, Brad O’Connor. “This is one solution from two market leaders, so it is very much aligned to the ‘best-of-breed’ approach that many sponsors are taking for their outsourcing strategies; particularly in the area of CNS where signal detection is so challenging and endpoint quality assurance is so critical.”

“The benefits of eSource for CNS research are dramatic,” stated Ed Seguine, CEO, Clinical Ink. “Combining Cogstate’s therapeutic expertise with our SureSource® platform, which directly captures data in the moment during the patient visit, promises to improve protocol execution. Researchers can focus more attention on the patient and the ratings when workflow and scoring are automated. This is an incredible time for CNS research and Clinical Ink is delighted to partner with a therapeutic leader like Cogstate on this advancement.”


This joint solution delivers important advantages to sponsors seeking to transcend traditional paper-and-pencil assessment scales in their clinical trials, including:

  • Custom edit checks, programmed workflows, and automated scoring at the point-of-care that prevent clerical errors and miscalculations
  • Same day access to quality source data and documents for central monitoring by Cogstate’s network of local expert advisors (LEADs), with custom flagging algorithms designed by clinical scientists for rapid identification of rater variance
  • Rater training that reaches beyond the investigator meeting and eLearning platforms by elegantly incorporating rater guidance directly into the rating scale instrument used during the patient visit for more accurate, standardized administration

A growing library of enhanced electronic scales ready for study-specific licensing and protocol customization
Key Learnings from a recent multi-site study will be presented in a live educational webinar, taking place November 9th at 11:00 a.m. EST.


About Cogstate

Cogstate Ltd (ASX:CGS) is a leading cognitive science company dedicated to simplifying the measurement of cognition in clinical trials, academic research and healthcare. Cogstate provides expert support for traditional neuropsychological and functional assessments to drive higher quality measures, and commercializes rapid, reliable and highly sensitive computerized cognitive tests. Cogstate customers include the world’s leading biopharmaceutical companies; military and elite sporting organizations; physicians and patients; renowned academic institutions and public-private partnerships.

Media Contact: Rachel Colite | 203.773.5010 | rcolite@cogstate.com

About Clinical Ink

Clinical Ink is a global clinical trial technology company that is transforming the clinical trial experience. Founded in 2007, the Company’s proven and future-built eSource platform, which includes solutions for EDC replacement, eCOA, ePRO and more, accelerates time to value while delivering scientific results that matter. With offices in Winston-Salem, NC, and Philadelphia, PA, Clinical Ink is advancing the business model responsible for bringing new treatments to market.

Media Contact: Jessica Romero | 336.728.6541 | jessica.romero@clinicalink.com

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Clinical ink and endpoint Announce ‘Industry-First’ Alliance https://www.clinicalink.com/clinical-ink-and-endpoint-announce-industry-first-alliance/ https://www.clinicalink.com/clinical-ink-and-endpoint-announce-industry-first-alliance/#comments Wed, 17 Apr 2019 16:55:37 +0000 https://www.clinicalink.com/uncategorized/clinical-ink-and-endpoint-announce-industry-first-alliance/ eSource and IRT Integration Simplifies the Site Experience SAN FRANCISCO, CA & PHILADELPHIA, PA – May 18, 2017  Endpoint Clinical, the leading global interactive response technology […]

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eSource and IRT Integration Simplifies the Site Experience

SAN FRANCISCO, CA & PHILADELPHIA, PA – May 18, 2017  Endpoint Clinical, the leading global interactive response technology (IRT) company, and Clinical ink, the pioneering provider of eSource and patient engagement technologies, have teamed up to integrate IRT and eSource in order to create a seamless user experience for investigator sites.

“The workload on investigator sites has steadily increased over the years; each technology advancement requires the site to learn new tools, remember more usernames and passwords, and work with yet another siloed data set for reporting” said Chuck Harris, CEO endpoint. “The endpoint-Clinical ink integration enables clinicians to focus their energy on what matters the most –  patient care.”

This collaboration between endpoint and Clinical ink integrates Clinical ink’s SureSource eSource platform and endpoint’s PULSE™ IRT.  Clinicians electronically record protocol required source data while accessing best-in-class IRT functionality to randomize patients and manage mission-critical clinical supply information through a single system during the patient visit.

“Clinical ink’s novel approach to capture clinical trial source data electronically during a patient visit coupled with endpoint’s IRT solution is a tremendous benefit for both sites and sponsors,” said Jonathan Andrus, COO Clinical ink.  “From the site perspective, it just made sense for us to collaborate – both the IRT and eSource system rely on the same patient data; our combined solution reduces the effort and risk of managing data across multiple platforms, helping to improve protocol execution.”

Otsuka Pharmaceuticals has provided critical support and guidance as this relationship evolved.  Their early adoption of eSource and vision of how other systems could be integrated created a lot of momentum for this ‘industry-first’ initiative.  “This effort not only improves the day-to-day operations and compliance of our clinical studies, but improves the speed with which we can obtain insights in to study data,” said Shashank Rohatagi, PhD, MBA, Leader, Data Sciences, Otsuka Pharmaceutical Development and Commercialization.  “In addition to reducing the burden on clinical site personnel, the ability to increasingly integrate our clinical trial systems is key to real time access and insights of our clinical trial data; something not feasible in the past.”

Combining eSource and IRT, benefits both sites and sponsors by simplifying the critical randomization and tedious supply accountability tasks that typically require so much time and effort.  Clinical ink and endpoint Clinical are committed to continuously improving the utility of this ‘industry-first’ alliance to reduce the burden on sites and improve data quality for sponsors.

About endpoint

endpoint is an interactive response technology (IRT®) systems and solutions provider that supports the life sciences industry. Since 2009, we have been working with a single vision in mind, to help sponsors and pharmaceutical companies achieve clinical trial success. Our solutions, realized through the proprietary PULSE® platform have proven to maximize the supply chain, minimize operational costs, and ensure timely and accurate patient dosing. endpoint is headquartered in San Francisco, California with a global footprint in the APAC region and Europe.

About Clinical ink

Clinical ink is a global clinical trial technology company that is transforming the clinical trial experience. Founded in 2007, the Company’s proven and future-built eSource platform, which includes solutions for EDC replacement, eCOA, ePRO and more, accelerates time to value while delivering scientific results that matter. With offices in Winston-Salem, NC, and Philadelphia, PA, Clinical ink is advancing the business model responsible for bringing new treatments to market. Visit clinicalink.com.

Media Contact: Jessica Romero | 336.728.6541 | jessica.romero@clinicalink.com

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