Decentralized Clinical Trials (DCTs)

Providing patient-centric clinical trial services to bring your therapy to patients' doorsteps.

Decentralized Clinical Trials (DCTs) redefine the landscape of clinical research by leveraging local or mobile healthcare providers to conduct remote study visits, procedures, and data collection in convenient locations for the patient, such as the comfort of their own home, offering a patient-centric approach and broadening the reach of the study.

ProPharma specializes in providing bespoke DCT services for every trial utilizing either a hybrid or fully virtual model to test your device or drug.

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What Is a Decentralized Clinical Trial? 

Decentralized clinical trials revolutionize traditional trial methodologies by bringing trial activities and medical technology directly to patients, reducing or eliminating the need for patients to visit traditional brick and mortar sites. This patient-centric approach lessens patient burden, enhances recruitment and retention rates, and ensures diverse participant inclusion allowing for trials to be therapeutically agnostic.

In addition, DCTs promote the use of technology, such as medical devices and telehealth visits, by offering 24/7 patient support and training. Our DCT model extends the site’s geographical reach and prioritizes patient experience while delivering reliable and real-time data to sponsors. This flexible approach also helps drive down sponsor costs and reduce trial timelines. With ProPharma’s team of GoClinical Clinicians who specialize in home health visits and are trained on GCP, IATA, and protocol-specific procedures, patients have the option to complete the trial in the most convenient location for them.

Patient Centricity is Therapeutically Agnostic

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Has a generally busy and active lifestyle

  • Dermatology
  • Rheumatology
  • Gastrointestinal
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Resides in a rural area or hours from the site

  • Rare and Orphan Diseases
  • Vaccines
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Requires assistance or a caregiver

  • Geriatric
  • Pediatric
  • Neurology
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Frail, immuno-compromised, mobility issues

  • Oncology
  • Musculoskeletal
  • Immunology

Traditional Clinical Trial Pain Points

70 %

of patients live more than two hours from a research site

87 %

of Sponsors planned to utilize decentralized clinical trials in 2022; only 28% planned to use DCT before the pandemic

85 %

of trails fail to retain enough patients

Real World Evidence: ProPharma’s DCT Team Sets the Standard in Home Health

ProPharma differentiates our home health/DCT offering through execution and commitment. This biotech company has used many home health vendors over the past ten years and they have felt the difference working with the ProPharma DCT team.

"Wish to thank you and your team for the simply superlative work you have done. You have been the champions for this study, and time and time again, you all have come through successfully through thick and thin."

Medical Director
Biopharmaceutical Customer

Real World Evidence: ProPharma’s DCT Team Sets the Standard in Home Health

ProPharma differentiates our home health/DCT offering through execution and commitment. This biotech company has used many home health vendors over the past ten years and they have felt the difference working with the ProPharma DCT team.

"Wish to thank you and your team for the simply superlative work you have done. You have been the champions for this study, and time and time again, you all have come through successfully through thick and thin."

Medical Director
Biopharmaceutical Customer

Decentralized Clinical Trial Benefits

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Improves patient safety, comfort, and convenience

Improves patient safety, comfort, and convenience

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Expands recruitment geography, enabling greater participation

Expands recruitment geography, enabling greater participation

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Increases retention

Increases retention

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Decentralized Clinical Trials icon

Larger, more diverse pool of patients

Larger, more diverse pool of patients

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Project based solutions icon

Reduce number of sites needed

Reduce number of sites needed

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Real-time date capture

Real-time date capture

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Flexible staffing model

Flexible staffing model

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In-person relationship building

In-person relationship building

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Full Service Clinical Trials icon

Eliminates need for transportation

Eliminates need for transportation

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Key Decentralized Visit Assessments

Our decentralized visits encompass a multitude of critical trial procedures, ensuring success. Our capabilities include: 

  • Vital Signs Monitoring
  • Lab Sample Collection and Processing
  • Physical Exams
  • Other Safety Assessments
  • Investigational Product (IP) Logistics, Accountability, and Administration
  • Telehealth Visits
  • Patient Training and Support
  • Medical Device Support and Training
Health care worker showing patient something on mobile phone

Why Decentralize Your Trial with ProPharma?

Study Management & DCT

Single Provider

  • We support traditional study management and mobile healthcare
  • Streamlined communication, start-up, and ongoing processes
  • Reduced vendor management and integrated meetings

GoClinical Clinicians (GCCs)

Employee Nurses

  • GCCs are directly employed in North America, Europe, and Australia
  • Ease & Speed to add GCCs by leveraging 25,000+ qualified, global providers currently in our database
  • Oversight by our Director of Nursing and local GCC/Nurse Managers
  • Extensive training in GCP, IATA, and protocol-specific purposes

GoClinical

eSource Platform

  • Proprietary eSource platform used to capture source documents at each visit and submit data to sites in real time
  • 21 CFR Part 11 and GDPR compliant
  • Customized per protocol and visit procedures

Industry Leaders

DCT Expertise

  • Operational leaders who have been working in the decentralized clinical trial/mobile healthcare space for 10+ years
  • Our team has supports 100s of DCT studies and will leverage our expertise and operational best practices to ensure success as well as provide transparency
  • Available for consultation to support decentralized study design

GoClinical System

Designed for streamlined success.

21 CFR Part 11 and GDPR web-based eSource application

Accessible via mobile device or desktop browser.

Why GoClinical?

  • Record and submit source data in real time
  • Reduce source turnaround times and allow for faster data entry in EDC
  • Reduce documentation errors
  • Improve PI oversight and safety

Customizable per protocol and visit procedures

  • Source forms are designed during study set-up and approved by Sponsor prior to implementation
  • Able to include job requisition form upload
  • Each record includes an audit trail

Role-based access with distinct UI and permissions for each role

  • GoClinical Clinician (GCC)
  • ProPharma Reviewer
  • Site Staff

What is ProPharma's GoClinical System?

Experience streamlined success with GoClinical, ProPharma's proprietary eSource system. Our platform enables clinicians to record and submit data in real-time, dramatically reducing source turnaround times and speeding up data entry into the EDC system. By using GoClinical, we minimize documentation errors, enhance PI oversight, and ensure greater safety in clinical trials. GoClinical makes data management faster, more accurate, and more efficient.

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Group of professional women talking in a lobby

Which ProPharma DCT Model is Right for Your Study?

  • Hybrid Clinical Trials – Maintains site involvement by conducting some visits on site while offering patients the option of conducting remote-friendly visits at alternate locations, such as their homes or offices. This model synergizes well with outsourcing, allowing companies to tailor their trial processes. 
  • Virtual Clinical Trials – Conduct all visits remotely, providing ultimate convenience for participants. ProPharma stands among the select few companies offering virtual decentralized clinical trials. 

While Hybrid Clinical Trials are preferred by most sponsors, our team is adept at supporting both Hybrid and Virtual models. Unsure where to start? With over a decade of experience in the decentralized clinical trial space, our experts can guide your company through the selection process, ensuring the right fit for your study.

Our Decentralized Clinical Trial Experts

  • Shelby Stillwagon Bio Photo

    Shelby Stillwagon

    Vice President, Decentralized Clinical Trials

    View Bio

  • Amy Scalise Bio Photo

    Amy Scalise

    Associate Director, Decentralized Clinical Trial Management

    View Bio

Shelby started her career in academic research, then moved to the clinical site environment, working in oncology, and has spent the past 11 years focused on supporting and operationalizing Decentralized Clinical Trials. Since 2013, Shelby has worked with numerous sponsors across hundreds of clinical trials, where she has provided expert guidance on decentralized visit design and logistics. She has held multiple oversight roles, supporting global teams across a wide variety of therapeutic areas including rare disease, pediatrics, oncology, neurology, and infectious diseases. Her expertise lies in collaborating with involved stakeholders to build and maintain study-specific, quality-focused processes that support complex decentralized clinical trials.
Amy began her career in the industry more than 15 years ago as a clinical research nurse and has progressively advanced to leadership roles. She has been instrumental in the initiation, planning, and management of numerous clinical trials across various therapeutic areas.

For the past 12 years, her focus has been on Decentralized Clinical Trial (DCT) services, providing expert guidance and operational support for studies in oncology, neurology, rare diseases, and infectious diseases. She has overseen global teams, ensuring the implementation of study-specific processes that meet regulatory requirements and maintain high-quality standards. Amy excels in stakeholder collaboration, training, and protocol development, supporting the successful execution of complex decentralized clinical trials. Her dedication to excellence ensures that all aspects of study management are meticulously handled, from project planning to regulatory compliance.

Partner with ProPharma for comprehensive decentralized clinical trial solutions tailored to your study needs.

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