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Decentralized Clinical Trials (DCTs)

Decentralized Clinical Trials (DCTs)

DCTs, conducted remotely or through local healthcare providers, improve the patient experience while creating a larger population for drug and device companies to test their products and ensuring participant health and safety.

In-Depth Experience Across All Phases

From early concept development through each clinical phase, product launch, and commercialization, ProPharma Group partners with emerging pharmaceutical, biotechnology, and medical device clients to tackle complex challenges. Our clinical trial experience includes over 20 years across Phase I-IV studies and a wide range of therapeutic areas. We help to ensure regulatory expectations are met, business goals are achieved, and patient health and safety is improved.

A Full Range of Services

  • An expansive network of pre-vetted, qualified, at-the-ready, licensed medical providers, including travel nurses
  • Complete clinical operations and trial management, including:
    • Feasibility study and budgeting
    • Ethics/Institutional Review Board (IRB) package creation, notification, and submissions
    • Study management and project oversight
    • Quality control and assurance, ensuring all activities are performed according to The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP), and applicable Standard Operating Procedures (SOPs)
    • Process standardization
    • Project and program management
    • Study forms, tools, and tracker creation
    • Third-party vendor management when needed
    • Patient recruitment and retention
  • Data capture through our proprietary technology, GoClinical, as well as Trial Master File (TMF) set up, maintenance, and reconciliation
  • Decentralized services including:
    • Drug administration, blood draws, and biologic sampling
    • Clinical assessments
    • Patient training, education, and surveying
    • Compliance checks

Why Decentralize Your Trial?

Once viewed as nice-to-have pilot projects, DCTs will quickly become a strategic priority, benefiting both the participants and the Sponsors.

ProPharma Group recognizes that patients are not just statistics or data – they’re people. For many potential clinical trial participants, managing a health condition is only one aspect of their life. In addition, they are running businesses, working full-time jobs, and raising families. Requiring these patients to attend site visits, which typically involves hours of travel time and additional costs, is a lot to ask, and for some, can be impossible.

From eliminating transportation and site set-up cost and hassle to capturing real-time data, there are countless reasons to consider a decentralized clinical study. For participants, geographical barriers are eliminated, giving you a larger, more diverse pool of eligible patients to sample from – allowing for an easier recruitment process. Additionally, patient safety and comfort are increased, while an in-person clinical relationship is built, increasing patient trust and retention.

Why Choose ProPharma Group’s Decentralized Clinical Trials?

Nursing

ProPharma Group has an expansive network of 17,000 qualified medical providers, including more than 12,000 nursing professionals. Additionally, we have the resources and relationships at the ready to source the exact talent needed for your particular clinical trial.

Technology

GoClinical, our proprietary technology platform, allows for the sourcing and scheduling of critical trial components as well as provides for direct, on-site data collection. Information is uploaded to an electronic data center for further analysis by the Clinical Trial Manager.

Experience

Operating from 35 offices worldwide, ProPharma Group is an expert in all aspects of Clinical Research Solutions and has been a full-service provider for over 25 clinical trials.

Therapeutic Expertise

Our team has vast experience managing studies across all therapeutic areas and phases for clinical and device trials. Among the most common:

  • Anti-infectives
  • Neuroscience/neurology
  • Cardiovascular
  • Oncoimmunology
  • Central nervous system
  • Oncology
  • Dermatology
  • Ophthalmology
  • Medical device and diagnostics
  • Pulmonary/respiratory
  • Endocrine/metabolic
  • Rare and orphan diseases
  • Gastrointestinal
  • Rheumatology
  • Immunology
  • Vaccines
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Need Help With Your Clinical Trials?

Complete the form or call us at 877-808-5675 to discover we can assist at any phase of development.

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