DCTS

PCM Trials Acquires EmVenio Research to Create the Most Patient-Centric Model for Hybrid and Decentralized Clinical Trials

Retrieved on: 
Friday, February 23, 2024
African Americans, Acquisition, CTS, FDA, Hispanic, RFP, Patient, Clinical trial, DCTS, Research, Travel

DENVER, Feb. 23, 2024 /PRNewswire/ -- Denver-based PCM Trials, the largest independent mobile research nurse visit provider for decentralized clinical trials (DCTs), today announced the acquisition of EmVenio Research based in Durham, North Carolina. EmVenio is the largest provider of community-based clinical trial sites served with mobile research units. The acquisition, which is effective immediately, strengthens PCM Trials' and EmVenio's abilities to recruit and retain diverse populations for clinical research studies, as required for regulatory approval. Site networks are key to delivering critical study data for sponsors; by combining capabilities with EmVenio, PCM Trials now has access to a site network that is focused on serving underrepresented patient populations in previously hard-to-reach communities and can work flexibly with sponsors to achieve their study goals.

Key Points: 
  • DENVER, Feb. 23, 2024 /PRNewswire/ -- Denver-based PCM Trials , the largest independent mobile research nurse visit provider for decentralized clinical trials (DCTs), today announced the acquisition of EmVenio Research based in Durham, North Carolina.
  • The acquisition, which is effective immediately, strengthens PCM Trials' and EmVenio's abilities to recruit and retain diverse populations for clinical research studies, as required for regulatory approval.
  • "The acquisition of EmVenio is an important part of our company's overall strategy to further remove barriers for patients of all backgrounds and ethnicities to participate in clinical research, creating the most patient-centric clinical trial model," said Greg Austin, President of PCM Trials.
  • On January 10, the company announced the acquisition of Netherlands-based Clinical Trial Service (CTS), which solidified PCM Trials' ability and reach to successfully conduct global clinical trials.

Medidata Secures Top Honors in Everest Group's Decentralized Clinical Trial Platforms PEAK Matrix® Assessment

Retrieved on: 
Wednesday, January 10, 2024
Software, Research, Professional Services, Pharmaceutical, Data Management, Technology, Medical Devices, Health Technology, Data Analytics, Clinical Trials, Science, Biotechnology, Health, Cloud, Patient, DCTS, Clinical trial, Dassault Group, Investment, DCT, Pharmaceutical industry

The report evaluated the vision, capabilities, and market impact of 22 decentralized clinical trial (DCT) platform providers based on relevant customer case studies, revenue, key offerings, and their latest progress.

Key Points: 
  • The report evaluated the vision, capabilities, and market impact of 22 decentralized clinical trial (DCT) platform providers based on relevant customer case studies, revenue, key offerings, and their latest progress.
  • “Medidata’s unified platform harnesses DCT technology to optimize patient, site, and sponsor experiences, delivering more inclusive studies,” said Anthony Costello, chief executive officer, Medidata Patient Cloud, Medidata.
  • With deep domain expertise, strategic partnerships, and industry experience, Medidata has achieved widespread adoption of its solutions,” said Nisarg Shah, practice director at Everest Group.
  • “Its investments in building a unified experience for sites and patients have positioned Medidata as a Leader and a Star Performer in the Decentralized Clinical Trial Platforms PEAK Matrix Assessment 2023.”
    Medidata’s platform has powered nearly 1,700 DCTs and over 1.1 million patients across disease areas, countries, languages, and clinical trial phases.

Novotech Identifies Decentralized Clinical Trials Potential and Challenges for Accelerating Global Biotech Clinical Trials in 2024

Retrieved on: 
Sunday, November 26, 2023
Conference, Trust, Drug development, Telehealth, Research, DCTS, ICN, Clinical trial, Patient, Clinical, Communication, Pharmaceutical industry

Michael Stibilj, Novotech's Chief Operating Officer, will discuss the potential, challenges, and practical applications of Decentralized Clinical Trials (DCTs) from a global biotech CRO perspective.

Key Points: 
  • Michael Stibilj, Novotech's Chief Operating Officer, will discuss the potential, challenges, and practical applications of Decentralized Clinical Trials (DCTs) from a global biotech CRO perspective.
  • According to Michael Stibilj, DCTs offer an advantage in terms of potential for substantial patient recruitment and retention.
  • Currently only 5% of eligible patients are participating in clinical research.
  • According to the organizers, this year’s conference titled Clinical Research Success through Good Governance aims to facilitate communication and knowledge sharing within the global biotech research communities.

Crowell Health Solutions Examines the Adoption of Decentralized Clinical Trials and Provides Policy Recommendations

Retrieved on: 
Tuesday, November 28, 2023
Health equity, Research, Policy, Food, ONC, Privacy, Collection, Clinical trial, Patient, FDA, DCT, Crowell & Moring, Interoperability, Biomedical Research, CMS, HHS, Cancer, Civil and political rights, Medicare, Congress, OCR, NIST, Outline, Environment, Legislation, MIPS, Medical device, Pharmaceutical industry, DCTS

Crowell Health Solutions published today a white paper outlining several policy recommendations to advance widespread adoption of decentralized clinical trials (DCTs).

Key Points: 
  • Crowell Health Solutions published today a white paper outlining several policy recommendations to advance widespread adoption of decentralized clinical trials (DCTs).
  • The white paper titled, "Advancing Adoption of Decentralized Clinical Trials: Rationale, Current State, and Policy Recommendations" examines the current environment on decentralized and hybrid clinical trials, including a discussion on benefits and challenges that DCTs may pose; existing legislation and regulation; and background on programs and policies, not specific to DCTs or clinical trials, that can be leveraged to support DCT adoption.
  • These recommendations were developed through rigorous discussions where health care industry stakeholders – patient and cancer advocacy groups, health care associations, pharmaceutical companies, and health technology companies – evaluated policy and clinical gaps in the current regulatory framework governing DCTs.
  • For additional information and to read the full white paper, visit Crowell Health Solutions .

Government Agencies Emphasize the Importance of Decentralized Methodologies for Future of Clinical Research

Retrieved on: 
Wednesday, November 8, 2023
SCRS, FDA, DCT, Biomedical Advanced Research and Development Authority, Office of the National Coordinator for Health Information Technology, National Institutes of Health, Face, European Medicines Agency, Organization, BARDA, Entrepreneurship, Research, Development, DTRA, DCTS, Clinical trial, Decentralized Trials & Research Alliance, EMA, Annual general meeting, NIH, Government agency, ONC, Chairperson, Map, Government, SAN, Pharmaceutical industry, Medical device

SAN DIEGO, Nov. 08, 2023 (GLOBE NEWSWIRE) -- The Decentralized Trials & Research Alliance (DTRA), a global alliance focused on the adoption of decentralized trials, today concluded its 2023 Annual Meeting, including members from biopharmaceutical companies, government agencies, research sites, healthcare organizations, patient groups, and service and technology companies.

Key Points: 
  • SAN DIEGO, Nov. 08, 2023 (GLOBE NEWSWIRE) -- The Decentralized Trials & Research Alliance (DTRA), a global alliance focused on the adoption of decentralized trials, today concluded its 2023 Annual Meeting, including members from biopharmaceutical companies, government agencies, research sites, healthcare organizations, patient groups, and service and technology companies.
  • The DTRA community learned of their strategic intentions regarding decentralized clinical trial (DCT) adoption, drivers to achieve scale with these methods, and the importance of DCT to our research ecosystem.
  • DTRA has harnessed this industry-leading expertise into creating new resources, sharing key learnings, and establishing best practices for research teams to use in implementing DCTs.
  • “Each of our Initiative outputs is available at www.dtra.org and the resources are available to all.”

Medable Wins 2023 Prix Galien Award for Best Digital Health Solution

Retrieved on: 
Monday, October 30, 2023
Technology, Research, Clinical Trials, Health Technology, Software, Biotechnology, Health, Pharmaceutical, Science, Drug development, Bristol Myers Squibb, Health technology, Incubator, ChromeOS, Creativity, Multimedia, Tufts Center for the Study of Drug Development, Digital health, DCTS, Boehringer Ingelheim, Nobel Prize, ARD International Music Competition, Patient, Pharmaceutical industry

Medable Inc. , the leading technology provider for modern clinical trials, today announced that its evidence generation platform was awarded “Best Digital Health Solution” from a field of 24 nominees at the Prix Galien USA Forum in New York City.

Key Points: 
  • Medable Inc. , the leading technology provider for modern clinical trials, today announced that its evidence generation platform was awarded “Best Digital Health Solution” from a field of 24 nominees at the Prix Galien USA Forum in New York City.
  • Worldwide, the Prix Galien Award is regarded as the equivalent of the Nobel Prize for the life science industry.
  • Winners from this year’s cohort include respected companies such as Bristol Myers Squibb, Eli Lily and Company, Novo Nordisk Inc., Boehringer Ingelheim and more.
  • View the full release here: https://www.businesswire.com/news/home/20231030126847/en/
    Medable Wins 2023 Prix Galien Award for Best Digital Health Solution (Graphic: Medable)
    Nine of the top 10 largest Contract Research Organizations (CROs) and 14 of the top 20 world’s largest pharmaceutical companies trust Medable’s platform and have deployed its technology in 300 clinical trials in 60 countries and 100+ local languages, touching the lives of more than one million patients and research participants globally.

Curavit Launches Health Economics and Outcomes Research (HEOR) Practice for Pharmaceutical Clinical Trials; Increasingly Critical for Digital Therapeutics

Retrieved on: 
Tuesday, October 31, 2023
Digital, Research, Insurance, Therapy, Government, Orchestra, Mortality, Conditional sentence, DTA, Geography, Environment, DCTS, Clinical trial, Walking, Single-frequency network, Language, Patient, Outcome, Pharmaceutical industry, Nursing, Stroke

NEW YORK, Oct. 31, 2023 /PRNewswire/ -- Curavit Clinical Research, a virtual contract research organization (VCRO) that specializes in decentralized clinical trials (DCTs) for digital therapeutics (DTx), launches new Health Economics and Outcomes Research (HEOR) Practice.  Curavit will incorporate HEOR services in clinical trials to capture evidence of the health economics value of novel pharmaceutical products, especially digital therapeutics which are striving to accelerate market momentum. Curavit will assess the value and effect of DTx interventions on both individual patients and population health levels of care.

Key Points: 
  • NEW YORK, Oct. 31, 2023 /PRNewswire/ -- Curavit Clinical Research , a virtual contract research organization (VCRO) that specializes in decentralized clinical trials (DCTs) for digital therapeutics (DTx), launches new Health Economics and Outcomes Research (HEOR) Practice.
  • Curavit will incorporate HEOR services in clinical trials to capture evidence of the health economics value of novel pharmaceutical products, especially digital therapeutics which are striving to accelerate market momentum.
  • Curavit will assess the value and effect of DTx interventions on both individual patients and population health levels of care.
  • Curavit and the Digital Therapeutics Alliance will be co-hosting educational events on November 3 in Boston, and December 7 in San Francisco.

Medable Partners with Pluto Health to Optimize Patient Experience and Improve Access to Clinical Trials

Retrieved on: 
Tuesday, October 3, 2023
Data Management, Biotechnology, Technology, Health, General Health, Security, Apps, Applications, Software, Networks, Internet, Clinical Trials, Partnership, Tufts Center for the Study of Drug Development, Clinical trial, Multimedia, Research, DCTS, Pluto, Organization, Patient, Cancer, Drug development, Female, Pharmaceutical industry, Nursing

Medable Inc. , the leading technology provider for modern clinical trials, announces an enterprise partnership with Pluto Health , a smart care coordination services company.

Key Points: 
  • Medable Inc. , the leading technology provider for modern clinical trials, announces an enterprise partnership with Pluto Health , a smart care coordination services company.
  • The strategic partnership brings together two best-in-class solutions – Pluto Health’s health coordination platform and Medable’s digitally enabled clinical trials platform – to accelerate clinical development, increase access to clinical research, and improve data quality.
  • View the full release here: https://www.businesswire.com/news/home/20231003413736/en/
    Medable Partners with Pluto Health to Optimize Patient Experience and Improve Access to Clinical Trials (Graphic: Business Wire)
    The success of a clinical trial depends on its ability to enroll a prespecified and representative number of study participants within a planned time frame while ensuring quality data is collected to meet study objectives.
  • Medable and Pluto Health’s combined technologies will streamline enrollment and retention efforts by supporting the patient experience while facilitating easier recruitment and monitoring.

MedRhythms Selects Curavit as its Contract Research Organization (CRO) for a Chronic Stroke Decentralized Clinical Trial

Retrieved on: 
Wednesday, September 20, 2023
Single-frequency network, Music, Partnership, Institutional review board, Success, Clinical trial, Research, Brain, DCT, DCTS, Walking, RAS, Patient, IRB, Orchestra, Outcome, Health, Pharmaceutical industry, Stroke

NEW YORK, Sept. 20, 2023 /PRNewswire/ -- Curavit Clinical Research, a virtual contract research organization (VCRO) that specializes in decentralized clinical trials (DCTs) for digital therapeutics (DTx), announced that it was selected as the VCRO for a study of MR-001, MedRhythms' neurorehabilitation system designed to improve walking and ambulation in adults with chronic stroke walking impairments. The goal of the study is to further characterize the long-term economic and clinical benefits of MR-001 beyond what has been established in a multi-center, randomized clinical trial. This will also include evaluating patient engagement and therapeutic response durability.  

Key Points: 
  • The goal of the study is to further characterize the long-term economic and clinical benefits of MR-001 beyond what has been established in a multi-center, randomized clinical trial.
  • Curavit is responsible for managing all aspects of MedRhythms' hybrid decentralized clinical trial (DCT) – from protocol finalization and Institutional Review Board (IRB) approvals to patient recruitment, testing at physical sites, remote site and patient monitoring and healthcare economics and outcomes analysis.
  • Health economics research quantifies the long-term financial impact for patients, providers, and payers," said Owen McCarthy, President and co-founder of MedRhythms.
  • MR-001 is based on Rhythmic Auditory Stimulation (RAS), a clinical intervention utilizing the mechanism of auditory-motor entrainment ("entrainment").

The Inflation Reduction Act: How Price Controls Could Disrupt Clinical Trials and Stifle Medical Innovation

Retrieved on: 
Monday, August 7, 2023
Cloud, Pressure, Software as a service, IPO, Medicare (United States), Drug development, Dissection, U.S. Department of Defense Strategy for Operating in Cyberspace, HHS, Human services, Survival, Tax, Clinical trial, Health, Medicare Part D, Research, Birth, COVID, Appetite, IRA, DCT, DCTS, Medicare, Inflation, Patient, Investment, Risk, Child, Informatics, Federation, Inflation Reduction Act of 2022, R, FDA, Conditional sentence, Fine chemical, Pharmaceutical industry

MANASSAS, Va., Aug. 7, 2023 /PRNewswire-PRWeb/ -- The Inflation Reduction Act (IRA) includes important provisions purported to lower drug spending and improve access to medications for many Americans. However, Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics, is raising concerns, "A key driver of the IRA regarding the cost of healthcare is placing pricing controls on drugs, decreasing the investment appeal in the biopharma sector, which is especially injurious to small and emerging biopharmaceutical companies who are already struggling to raise capital." The number of emerging biopharma companies has been consistently increasing by 4% each year for the past five years; they produced two-thirds of all new drugs in 2022. If this trend continues, emerging biopharma could account for 80% of the industry's research and development (R&D) pipeline by 2028.(1)

Key Points: 
  • Drug pricing controls imposed by the Inflation Reduction Act of 2022 may appear positive for patients in the short term.
  • MANASSAS, Va., Aug. 7, 2023 /PRNewswire-PRWeb/ -- The Inflation Reduction Act (IRA) includes important provisions purported to lower drug spending and improve access to medications for many Americans.
  • If this trend continues, emerging biopharma could account for 80% of the industry's research and development (R&D) pipeline by 2028.
  • Much of this new technological innovation has been aggregated under the umbrella of Decentralized Clinical Trials (DCT) or hybrid clinical trials.