Press Release on Clinical Research | Clinical ink https://www.clinicalink.com/press-release/ Tue, 01 Apr 2025 18:08:30 +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 Press Release on Clinical Research | Clinical ink https://www.clinicalink.com/press-release/ 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 Announces the Promotion of John Pappadakis to Chief Commercial Officer and Megan Petrylak to Chief Operating Officer https://www.clinicalink.com/clinical-ink-announces-the-promotion-of-john-pappadakis-to-chief-commercial-officer-and-megan-petrylak-to-chief-operating-officer/ Wed, 23 Oct 2024 11:59:14 +0000 https://www.clinicalink.com/?p=19886 Clinical ink, a global life science technology company, announces the promotion of John Pappadakis from EVP, Global Business Development to Chief Commercial Officer and Megan Petrylak from EVP, Clinical Operations to Chief Operating Officer.

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Prepares the company for diversified growth underpinned by operational and clinical excellence in clinical trial technology

Winston Salem, NC – Clinical ink, a global life science technology company, announces the promotion of John Pappadakis from EVP, Global Business Development to Chief Commercial Officer and Megan Petrylak from EVP, Clinical Operations to Chief Operating Officer. Jonathan Goldman MD, CEO of Clinical ink commented: “I am delighted to announce the promotion of two of our most seasoned and experienced executives.  With John Pappadakis as CCO, and Megan Petrylak as COO, Clinical ink has the ideal leadership team to drive us to the next phase of growth.  Our unwavering focus on quality and innovation make us the partner of choice for our biopharmaceutical partners and the patients they serve.”

John Pappadakis, Chief Commercial Officer

John has 34 years of experience in sales and marketing leadership roles within the pharma industry. His career includes commercial and R&D positions at Oracle and IMS Health, following positions of increasing seniority at Pfizer and Parke-Davis where he launched over 30 new molecular entities.

As Clinical ink’s EVP, Global Business Development, John devised an innovative go-to-market strategy centered around the addition of scientific and medical expertise, and the incorporation of new FDA requirements into the Clinical ink technology platform.  His vision inspired the creation of the company’s newest integrated cardiometabolic product, GlucoseReady™.  Under his leadership, the company recruited a world-class commercial team and demonstrated record levels of key BD metrics.

As Chief Commercial Officer, John will further diversify Clinical ink’s customer base with the addition of new large, medium and small biopharmaceutical companies, whilst solidifying the company’s CRO relationships and other industry alliances.  His plans include the deepening of the therapeutic area focus on cardiometabolic, CNS, immunology and oncology, the introduction of an end-to-end decentralized/digital health platform centered around eCOA and EDCXtra™, as well as new licensing-based business models.  Moving forward, John will be announcing novel and transformative AI-driven clinical trial innovations.

Megan Petrylak, Chief Operating Officer

Megan Petrylak has over 14 years of clinical trial experience in senior operational leadership roles. She has particularly focused on driving successful outcomes in phase 1-3 clinical trials for a wide range of global biopharmaceutical and CRO customers. Prior to her 6 year tenure at Clinical ink, Megan served as Director of Project Delivery at Worldwide Clinical Trials. Prior to that role, she headed Bioclinica’s centers for imaging and eClinical project management.

As EVP, Clinical Operations, Megan oversaw Clinical ink’s entire customer, site, and patient-facing operations function.  She augmented the team with deep expertise in data management and data quality, mandating a quality-first culture. This resulted in impressive increases in customer satisfaction, complemented by significant reductions in all study build and execution metrics and excellent quality outcomes.  In addition, Megan’s team successfully launched new products including GlucoseReady™ and EDCXtra™ and has developed a range of industry partnerships including TransPerfect for translations and eClinical Solutions for complex data solutions.  Her deep subject matter expertise in eCOA and data management has been recognized at numerous industry consortia and she has served as an expert speaker at meetings such as the Society of Clinical Data Management.

In her new role as Chief Operating Officer, Megan will oversee significant growth in Clinical ink’s revenue, broadening the customer base and expanding the range of integrated solutions. Her plans include upscaling the team to support the planned growth in revenue and margin profile, aided by automation of key operational and data processes. Megan will continue to prioritize quality to drive operational excellence and ensure exceptional delivery to clients.  

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, and digital biomarkers advancements (including use of Continuous Glucose Monitoring for detection of hypoglycemia), support the next generation of clinical trials and ultimately the clinical management of patients.

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Clinical ink announces EDCXtra™ : An integrated web-based EDC, DDC and eCOA platform https://www.clinicalink.com/clinical-ink-announces-edcxtra-an-integrated-web-based-edc-ddc-and-ecoa-platform/ Thu, 29 Aug 2024 15:24:06 +0000 https://www.clinicalink.com/?p=19771 Clinical ink announces EDCXtra: An integrated web-based EDC, DDC and eCOA platform.

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Adds web-based EDC to suite of eClinical technologies including DDC and complex eCOA

Winston-Salem, NCClinical ink, a global life science technology company, announced the launch of EDCXtra™, an innovative Electronic Data Capture (EDC) system. EDCXtra is based on the company’s best in class direct data capture (DDC)/eSource platform, which has evolved over 17 years, and resulted in multiple FDA approvals. EDCXtra incorporates all existing DDC functionality into a single web-based application which includes Clinical ink’s industry leading electronic Clinical Outcome Assessments (eCOAs) and eConsent solutions, providing a comprehensive, all-in-one GCP compliant platform.

EDCXtra is designed to operate in hybrid mode, allowing sites the flexibility of entering Case Report Form (CRF) data in real-time along with complex eCOAs in a single interface, or to use paper CRF transcription methods and enter data into the EDC later.

EDCXtra also offers electronic consent (eConsent) and integration via API with other eClinical systems including interactive response technology (IRT) and Laboratory Data. This fully customizable solution adapts to the specific needs of each trial.

“We developed EDCXtra to improve the site experience by providing a single flexible EDC/DDC solution,” said Megan Petrylak, EVP, Clinical Operations at Clinical ink. “The integration of EDCXtra in our end-to-end eClinical suite improves speed and quality of data capture while significantly reducing the administrative burden on sites. Sponsors benefit from the simplicity and cost advantage of a single study build for EDC and complex eCOAs, as well as the customizable integration of 3rd party data systems such as IRT and central laboratory.”

For more information about EDCXtra or to schedule a demo, please visit clinicalink.com or contact info@clinicalink.com.

About Clinical ink

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

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Clinical ink Appoints Dr. Nicholas Alp, MD PhD as Chief Medical Officer https://www.clinicalink.com/clinical-ink-appoints-dr-nicholas-alp-md-phd-as-chief-medical-officer/ Mon, 10 Jun 2024 11:59:56 +0000 https://www.clinicalink.com/?p=19495 Clinical ink announced the appointment of Dr. Nicholas Alp as Chief Medical Officer will lead the creation of innovative solutions and commercial strategies for clinical trial technology based on his experience as an interventional cardiologist and clinical trialist.

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Adds medical expertise and scientific thought leadership to cutting edge clinical research technology

Winston-Salem, NCClinical ink, a global life science technology company, announced the appointment of Dr. Nicholas Alp as Chief Medical Officer and EVP, Medical Science. In this role, Dr. Alp will lead the creation of innovative solutions and commercial strategies for clinical trial technology based on his experience as an interventional cardiologist and clinical trialist. His responsibilities will include the oversight of Clinical ink’s scientific advisory board, providing medical input to customer projects, and clinical focus to our range of products solutions.

Dr. Alp stated: “I am excited to join the leadership team at Clinical ink, where I look forward to helping my colleagues develop and deploy world-class data science solutions to enhance scientific insights and accelerate drug development for our Biopharma partners and for the benefit of patients”.

Dr. Alp has more than 30 years of clinical research experience and has spent the last 13 years in the life science industry. Prior to Clinical ink, he served as Senior Vice President of the Medical Department and head of Cardiometabolic Research at Medpace, a global clinical research organization.

Previously, Dr. Alp was Vice President and Global Head of Cardiovascular Drug Development at ICON. He simultaneously held appointments as a Consultant Interventional Cardiologist at the John Radcliffe Hospital, Oxford and a senior academic role in Cardiovascular Medicine at Oxford University.

Dr. Alp trained in medicine at London University and Oxford University, completed a PhD in Immunology at Cambridge University, with a further post-doctoral DM degree in Vascular Biology at Oxford University. He has also contributed to more than 70 peer-reviewed publications and books.

”I am delighted to welcome Nicholas to Clinical ink. He is a visionary clinician scientist with deep clinical research experience in cardiometabolic disease and other key therapeutic areas. Our customers and the patients they serve will benefit greatly from his ability to deploy clinically relevant eCOA, DDC, connected devices and patient engagement solutions” commented Clinical ink Chief Executive Officer Jonathan Goldman, MD.

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, and digital biomarkers advancements (including use of Continuous Glucose Monitoring for detection of hypoglycemia), support the next generation of clinical trials and ultimately the clinical management of patients.

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Clinical ink announces GlucoseReady™ https://www.clinicalink.com/clinical-ink-announces-glucoseready/ Tue, 23 Apr 2024 18:38:26 +0000 https://www.clinicalink.com/?p=19422 Clinical ink announces an integrated suite of eClinical tools for cardiometabolic clinical trials.

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An integrated suite of eClinical tools for cardiometabolic clinical trials

Winston-Salem, NCClinical ink, a global life science technology company, today announced the launch of GlucoseReady™, a fully integrated GCP compliant digital platform designed for the new era of cardiometabolic clinical trials. The suite of tools includes disease specific electronic clinical outcomes (eCOA) assessments, behavioral assessment by the SPUR™ tool, lifestyle standardization, blood (BGM) and continuous glucose monitoring (CGM), digital weight scale and actigraphy.  Unique endpoint features include ability of BGM and CGM to trigger hypoglycemia eCOA within the platform in line with the latest FDA guidance.  Novel compliance features include prediction, tracking and prevention of non-compliance and drop out at site and patient level. Partnerships with leading digital device developers further reinforce alignment with FDA expectation for regulatory compliance.

GlucoseReady™ provides modules which used separately or together support multiple therapeutic areas including diabetes, chronic weight management and obesity and NASH/MASH, within a single GCP platform designed for user friendliness, patient support as well as the requirements of an FDA inspection.

Jonathan Goldman, MD FACC FRCP, CEO of Clinical ink commented: “The next generation of Cardiometabolic trials require a new approach to understanding who the patients are and what they care about.  GlucoseReady™ is designed from the ground up to provide full real time transparency into patient behavior and lifestyle whist capturing the full range of relevant symptoms, signs and biomarkers.  We believe these user friendly tools can support the relationship between site and patient to improve the most important variable of all: retention.  In addition, near real time data visualization provides sponsors with a new gold standard for data science.”

About Clinical ink

Clinical ink is the global life science company bringing together data, technology, and patient-centric research. Our deep therapeutic area expertise, coupled with Direct Data Capture, eCOA, eConsent, Telehealth, and Digital Biomarkers advancements, including the use of Continuous Glucose Monitoring for the detection of hypoglycemia, support the next generation of clinical trials and, ultimately the clinical management of patients.

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Clinical ink Expands Patient Engagement Solutions with Behavioral Diagnostic Tool SPUR™ https://www.clinicalink.com/clinical-ink-expands-patient-engagement-solutions-with-behavioral-diagnostic-tool-spur/ Mon, 13 Nov 2023 19:08:53 +0000 https://www.clinicalink.com/?p=18985 Clinical ink is expanding its patient engagement suite with the inclusion of the SPUR™ behavioral diagnostic tool created by Observia.

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In partnership with Observia, Clinical ink incorporates leading behavioral science evaluation into its technology suite of assessments.

Winston-Salem, NCClinical ink,  a global life science technology company, is expanding its patient engagement suite with the inclusion of the SPURTM behavioral diagnostic tool created by Observia. This unique integrated solution combines assessment of patient behavior with lifestyle modification, eCOA, eSource, and Digital Biomarkers.  It is available for both clinical development and marketed pharmaceutical products.

SPURTM is a behavioral diagnostic tool that is used to determine adherence to protocol and drug, provide guidance for lifestyle changes, and modify behavior by personalized intervention. The tool has been validated in numerous patient populations including diabetes, hypertension, respiratory disease and others. It collects a comprehensive dataset of behavioral drivers (social, psychological, usage, and rational), that help quantify the motivation for each patients’ decision-making and allows for personalized support at the patient level.

The collaboration with Observia allows Clinical ink to capture a holistic view of patient behavior together with clinical outcomes and digital biomarkers.  Behavior and cognition represent a previously neglected dataset, permitting improved adherence to trial protocols and standardization of lifestyle advice in complex chronic indications.

Jonathan Goldman, MD, CEO of Clinical ink, commented: “I am delighted to announce this collaboration with Observia to create a best-in-class platform.  Understanding patient behavior is an essential but often overlooked component of clinical trials.  We hope this addition to our integrated technology solution will improve patient engagement with measurable benefits for patient adherence and trial outcomes.”

As the world of clinical trials transforms to become more digital, we are thrilled to bring our SPURTM profiling tool into the Clinical ink service offering. We strongly share Clinical ink’s vision that improving patient experience equals improving clinical trial performance,” says Kevin Dolgin, Head of R&D at Observia. 

To learn more about this partnership or our solutions, contact us here.

About Clinical ink

Clinical ink is the global life science company bringing together data, technology, and patient-centric research. Our deep therapeutic area expertise, coupled with Direct Data Capture, eCOA, eConsent, Telehealth, and Digital Biomarkers advancements, including the use of Continuous Glucose Monitoring for the 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 Introduces Breakthrough Solution to Drastically Reduce Study Build Timelines https://www.clinicalink.com/drastically-accelerate-study-build-timelines/ Thu, 12 Oct 2023 10:00:00 +0000 https://www.clinicalink.com/?p=18535 Clinical ink is setting a new industry benchmark in advancing study build timelines. Harnessing the power of the latest eCOA technology, Clinical ink can now reduce study build timelines to as little as 10 days.

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Innovative eCOA Technology Sets New Standard for Speed, Efficiency, and Accuracy in Study Build Process
 

Winston Salem, NC – Clinical ink, a global life science technology company, is setting a new industry benchmark in advancing study build timelines. Harnessing the power of the latest eCOA technology, Clinical ink can now reduce study build timelines to as little as 10 days.

Clinical ink’s scalable software solution offers enhanced precision right from the start to ensure trial success. Key features of Clinical ink cutting-edge eCOA technology include:

  • What You See Is What You Get (WYSIWYG) Design
    Streamline the instrument build process with a codeless GUI-driven design interface providing immediate and intuitive visibility into what sites and subjects will see.
     
  • Flexibility by Design
    Gain unprecedented flexibility with build tools that support collaborative work, enabling teams to concurrently work and alter a study’s design as needed.
     
  • Direct Translation System Integration
    Eliminate the need for manual file distribution and text copy through cumbersome channels, promoting efficiency.
     
  • Custom Library
    Dedicated repository of approved and validated content tailored to your specific needs.

Setting a 10-day benchmark in study build timelines is proof of the strength of the latest Clinical ink eCOA technology,” comments Megan Petrylak, EVP, Clinical Operations. “Clinical ink is redefining speed and raising the bar for efficiency and accuracy, ensuring that clinical study development is agile and meticulous.

Through a seamless, codeless user interface with direct integrations, Clinical ink eCOA advancements ensure a streamlined and precise study build process. These are the latest advancements delivered by Clinical ink, following its recently unveiled Data Management services, to further enhance its comprehensive range of eCOA, direct data capture, patient engagement, and digital biomarker solutions.

About Clinical ink

Clinical ink is the global life science company bringing together data, technology, and patient-centric research. Our deep therapeutic area expertise, coupled with Direct Data Capture, eCOA, eConsent, Telehealth, and Digital Biomarkers advancements, including the use of Continuous Glucose Monitoring for the detection of hypoglycemia, support the next generation of clinical trials and ultimately the clinical management of patients.

Ready to reduce your study build timeline?

Contact us today to discuss Clinical ink’s eCOA technology.

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Clinical ink Enhances Data Management Services, and Announces Senior Hires in Data Management and Data Integrity https://www.clinicalink.com/clinical-ink-enhances-data-management-services-and-announces-senior-hires-in-data-management-and-data-integrity/ Tue, 19 Sep 2023 16:31:26 +0000 https://www.clinicalink.com/?p=18460 Clinical ink, a global life science technology company, announces the appointment of Jeff Bock, Vice President of Data Management and Tom Haag, Vice President of Data Quality Control.

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Expansion of expertise and data solutions to drive growth for leading clinical technology provider.

 Winston Salem, NC – Clinical ink, a global life science technology company, announces the appointment of Jeff Bock, Vice President of Data Management and Tom Haag, Vice President of Data Quality Control. Bock will lead the development of the company’s data management strategy and expanding technology portfolio to support clinical trials. Haag will oversee the strategy and execution for ensuring the integrity of customer data sets.

Bock is an experienced data management executive with 20 years specializing in building and leading data management teams in the delivery of clinical trials. Prior to Clinical ink, Bock served as Executive Director, Data Operations Technical Services at Syneos – a leading CRO biopharmaceutical solutions organization.

Haag has a deep expertise in digital health and data integrity in clinical trials. He joins the company following senior roles at CRF and Novartis in digital development and quality assurance.

In addition to these appointments, Clinical ink launched a range of new Data Management services to support its comprehensive range of eCOA, direct data capture, patient engagement, and digital biomarker solutions. The Data Integrity service will include an analytics suite with checks on per-protocol compliance, cross-study data consistency and coherence, as well as anomaly and bias detection checks.

Jonathan Goldman, MD, Clinical ink’s Chief Executive Officer, commented: “I am delighted to welcome Jeff and Tom to Clinical ink. Their outstanding expertise is an important addition to our industry-leading data capture technologies. Our new data integrity solutions will reduce the burden on sites and sponsors by ensuring that the data entered by staff and patients is complete and of high quality, reducing data cleaning activities at the end of the trial. Moving forward, we expect to provide additional data integrations and services to improve the time and cost of projects and the experience for patients and sites.”

About Clinical ink

Clinical ink is the global life science company bringing together data, technology, and patient-centric research. Our deep therapeutic area expertise, coupled with Direct Data Capture, eCOA, eConsent, Telehealth, and Digital Biomarkers advancements, including the use of Continuous Glucose Monitoring for the detection of hypoglycemia, support the next generation of clinical trials and ultimately the clinical management of patients.

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Clinical ink Appoints Andrew Kraus as Chief Technology Officer https://www.clinicalink.com/clinical-ink-appoints-andrew-kraus-as-chief-technology-officer/ Tue, 20 Jun 2023 14:43:43 +0000 https://www.clinicalink.com/?p=17818 Clinical ink announced the appointment of Andrew Kraus as Chief Technology Officer who will lead the development of the company’s expanding technology portfolio to support clinical trials.

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Adds expertise and leadership in development of enabling clinical technologies.

Winston-Salem, NCClinical ink, a global life science technology company, announced the appointment of Andrew Kraus as Chief Technology Officer. In this role, Kraus will lead the development of the company’s expanding technology portfolio to support clinical trials.

Kraus is an accomplished global healthcare executive with a 30-year track record of successful innovation in clinical trials leveraging his background in technology, strategy, operations, and finance. Prior to Clinical ink, Kraus served as Chief Operating Officer for World Care Clinical, a CRO providing centralized imaging and other services supporting clinical trials. He currently sits on the Board of Directors for Algorics, a specialized clinical data services company.

Mr. Kraus commented: “I am passionate about making a meaningful difference for patients by streamlining the clinical trials process. There is so much opportunity to simplify the capture of clinical data from patients. I am very excited to drive innovation as part of the Clinical ink team as we lead the industry in the development and deployment of integrated clinical trial technologies.” 

Previously, Kraus held executive roles at several companies leading clinical technology and operations. These included experience as Chief Operating Officer at Bioclinica (now part of Clario), SVP Service, Strategy and Operations at Signant, as well as Chief Operating Officer and Treasurer for the Cardiovascular Research Foundation.

Kraus has deep knowledge of the clinical trial space, having co-founded Beacon Bioscience as Chief Technology Officer and overseen its growth into a global imaging and clinical event adjudication provider prior to acquisition by ICON plc to become ICON Medical Imaging, where he managed all of ICON’s imaging and data technology businesses.

“I am delighted that Andrew has joined us as CTO,” said Clinical ink Chief Executive Officer Jonathan Goldman, MD. “He brings tremendous expertise in the use of technology to solve unmet needs in clinical trials and patient care to our organization. He is the right person to lead the growth of our patient-centered technology platform.”  

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, and digital biomarkers advancements (including use of Continuous Glucose Monitoring for detection of hypoglycemia), support the next generation of clinical trials and ultimately the clinical management of patients.

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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 Work Demonstrating Technology Sensitivity to Parkinson’s Disease Published in Nature https://www.clinicalink.com/clinical-ink-work-demonstrating-technology-sensitivity-to-parkinsons-disease-published-in-nature/ Mon, 15 May 2023 15:59:02 +0000 https://www.clinicalink.com/?p=17633 Clinical ink announces the publication of “Using a smartwatch and smartphone to assess early Parkinson’s disease in the WATCH-PD study” in npj Parkinson’s Disease.

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Movement Disorders study application linked to Parkinsonian symptom severity

Horsham, PAClinical ink, a global life science technology company, announces the publication of “Using a smartwatch and smartphone to assess early Parkinson’s disease in the WATCH-PD study” in npj Parkinson’s Disease.

Baseline data from the WATCH-PD study—a longitudinal, multicenter study that deployed consumer-grade wearable and sensor devices loaded with a movement disorders application developed by Clinical ink—underwent feature engineering and statistical modeling to evaluate the technology’s sensitivity to symptoms of Parkinson’s disease. 

The application consisted of digital assessments of cognition, speech, and motor performance. Results demonstrated significant associations between the digital biomarkers developed from the wearable device and sensor data streams, and conventional clinical scoring methods used in Parkinson’s disease. 

“Parkinson’s disease is a neurodegenerative disease with increasing prevalence.  However, diagnosis of early Parkinson’s disease remains difficult due to complexity of symptoms,” said David Anderson, Ph.D., Principal Scientist at Clinical ink. “This publication demonstrates the potential use for consumer wearables in the detection and staging of early-stage Parkinson’s disease.” 

“We are thrilled to co-author this study in npj Parkinson’s Disease,” added Jonathan Goldman, MD, Chief Executive Officer of Clinical ink. “I am delighted that Clinical ink is taking a leadership role in clinical research applications of these novel technologies.  I hope that wearables and associated analytic tools can improve the lives of patients living with Parkinson’s disease and other movement disorders.”

The WATCH-PD study was funded with support from Biogen, Takeda, and the Critical Path for Parkinson’s Consortium 3DT.

About Clinical Ink

Clinical ink is the global life science company that brings 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 industry standard for data precision and usher in a new generation of clinical trials.

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Clinical ink Announces New Continuous Glucose Monitoring Solution https://www.clinicalink.com/clinical-ink-announces-new-continuous-glucose-monitoring-solution/ Tue, 25 Apr 2023 16:10:57 +0000 https://www.clinicalink.com/?p=17504 Clinical ink now offers continuous glucose monitoring (CGM) within its integrated digital biomarker solution.

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Provides data integration options to capture and analyze data from FDA-approved continuous glucose monitoring devices in clinical trials.

Winston-Salem, NC Clinical ink, a global life science technology company, now offers continuous glucose monitoring (CGM) within its integrated digital biomarker solution. The new modules enable remote collection, central storage, and analysis of sensor data from commercially available devices for use in diabetes clinical trials. The solution addresses device connectivity status, providing robust, on-device CGM data collection in both offline and online scenarios with efficient data synchronization management when connected. 

This integration is facilitated by the recent FDA clearance of commercial CGM devices, which include the Abbott FreeStyle Libre 3 System and the Dexcom G7 System. CGM is now also recommended in the expanded 2022 American Diabetes Association clinical guidelines for adults and children, as well as the 2022 FDA guidance on feasibility of use in diabetes clinical trials.  

“I am delighted that Clinical ink is leading the industry in the introduction of CGM as the latest addition to a comprehensive suite of digital biomarkers covering multiple therapeutic areas,” comments Jonathan Goldman, MD, CEO at Clinical ink., “These technologies have the potential to improve patient safety by increasing the frequency and resolution of real-time monitoring while decreasing clinical trial costs and time-to-decision.”

The Clinical ink data integration provides full centralized access to a suite of metrics that are compliant with CGM guidelines, along with behavioral, cognitive, and biometric measures. The ability to monitor the relationships between glucose levels, behavior, and physiological response in near real time provides unprecedented insights for actionable intervention and behavior modification. The solution completes the Clinical ink suite, which includes eCOA, decentralized clinical trial capabilities, and data science solutions that deliver complex diabetes protocols in the clinical environment.

“This work promises to expand Clinical ink’s data collection capabilities for diabetes clinical trials,” adds Stephen Polyak, PhD, VP of Engineering and Data at Clinical ink. “We believe CGMs are a valuable tool for clinical trials that will improve the quality and accuracy of glucose data, reduce participant burden, improve safety monitoring, and provide valuable longitudinal data.”

The addition of CGM capabilities further demonstrates the company’s commitment to providing innovative eClinical solutions for the pharmaceutical, biotechnology, and medical device industries. With this integration, Clinical ink solidifies its position as a leader in the industry, delivering advanced solutions for complex diabetes protocol design and deployment.

About Clinical ink
Clinical ink is the global life science company that brings 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 industry standard for data precision and usher in a new generation of clinical trials.   

The post Clinical ink Announces New Continuous Glucose Monitoring Solution appeared first on Clinical ink.

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