ProPharma offers Decentralized Clinical Trial (DCT) services in both a hybrid and fully virtual model to ensure whatever your needs are, we are able to accommodate them. If you need assistance with your trials, or help determining if a DCT model works for your project, reach out to our experts today for a consultation.
What Are Decentralized Clinical Trials?
Decentralized Clinical Trials (DCTs) are studies that are supported by local or mobile healthcare providers that focus on bringing activities to patients instead of bringing patients to trial sites. As a result, Decentralized Clinical Trials reduce patient burden while increasing patient recruitment, retention, and inclusion. The increased flexibility of DCTs expands the geographical reach, and enhances the patient experience while providing Sponsors with reliable data. Trial decentralization provides the opportunity for study visits to take place in a location convenient to the patient, supported by our team of GoClinical Clinicians who are trained in GCP and protocol-specific procedures. In fact, some patients may be eligible to receive in-home clinical trial services.
Statistics About Clinical Trials
- 70% of patients live more than two hours from a research site
- 87% of Sponsors plan to utilize DCT in 2022; only 28% planned to use DCT before the pandemic
- 85% of trials fail to retain enough patients
Benefits of Implementing a Decentralized Clinical Trial
- Improved patient recruitment and retention
- Expanded geographical reach
- Increased patient diversity
- Increased flexibility and convenience for patients, providing a differentiator for the Sponsor over competing studies
- Sites can enroll and complete high complexity visits while GoClinical Clinicians attend to frequent and routine visits in the field
- Ensured continuity of care if sites are unable to cover visits due to COVID-19 or other unforeseen issues
Typical Assessments for Decentralized Visits
Our decentralized visits include critical procedures for your clinical trial’s success. Let our team of experts review your protocol or draft synopsis and consult with your team on what visits or studies could benefit from a DCT model. Our procedural capabilities are as follows:
Vital Signs and Associated Variables
Lab Sample Collection and Processing
IP Logistics Per Protocol Assessments Targeted Nursing Assessments |
IP Administration
Telehealth Support Patient Reported Outcomes/Scales Patient Training
Other Safety Assessments
|
Why Decentralize Your Trial?
Once viewed as nice-to-have pilot projects, DCTs have quickly become a strategic priority – benefiting both the participants and the sponsors. Outsourcing DCT has become even more common with the pandemic, offering the continuation of clinical studies despite limited capabilities.
ProPharma 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. Requiring these patients and their families or caregivers 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, site set-up cost, and hassle to capturing real-time data, there are countless reasons to consider a decentralized clinical trial. For participants, geographical barriers are eliminated giving you a larger, more diverse pool of eligible patients to sample from – providing a more efficient recruitment process. Additionally, patient safety and comfort are increased, while an in-person clinical relationship is built, increasing patient trust and retention.
Which DCT Model is Right for Your Study?
- Hybrid Clinical Trials – sites are still involved in this model and patients have the option of having certain agreed-upon visits performed at a convenient, alternate location such as their home, office, school, etc. Hybrid models work well with outsourcing, as companies can choose specific aspects of their clinical trial in which to outsource.
- Virtual Clinical Trials – patients are never required to go to a site for study visits, all visits take place at an alternate location. ProPharma is one of a handful of companies that offer virtual decentralized clinical trials.
Most Sponsors are adopting a Hybrid Clinical Trial model, but our team is able to support both Hybrid and Virtual clinical trials.
Not sure where to start? Our team of experts has 10 plus years of experience in the DCT space and can help guide your company on what studies make sense for DCT or what challenges we would need to work through to implement a DCT model. Contact us to help determine which models work the best for your study.
Why Choose ProPharma’s Decentralized Clinical Trials?
Nursing
ProPharma has 300 full-time GoClinical Clinicians (RNs, LNs, and Phlebotomists) on staff to support your patients. Furthermore, we have an expansive network of more than 25,000 nursing professionals through our sister companies. This scope ensures that whatever your DCT needs are, ProPharma has the scale and capability to ensure your trial runs smoothly.
Technology
GoClinical, our proprietary 21 CFR Part 11 compliant technology platform, allows the collection of source data from decentralized visits and electronically sends it for entry into the EDC. This approach to source collection significantly reduces source turnaround times, reduces documentation errors, and improves PI oversight.
Experience and Global Reach
ProPharma has 27 offices worldwide spanning six continents, providing a truly global footprint to support your decentralized clinical trials. ProPharma has 20 years of experience supporting sponsors from early development through commercialization allows for expert insight at any phase or function of your study and a streamlined approach from a single provider. Our DCT leadership team has over ten years of experience in the DCT space to help your team design and implement the right DCT solutions. Whether you’re interested in hybrid or virtual clinical trials, our team of experts can help.
Therapeutic Expertise
Our team has vast experience managing studies across all therapeutic areas and phases for clinical and device trials. Among the most common:
|
|
Need Help Incorporating DCT into Your Clinical Trials?
We have more than 10 years of experience helping sponsors implement decentralized visits for their clinical trials.
News & Insights

September 27, 2023
The Impact of a US Government Shutdown on the Food and Drug Administration
U.S. lawmakers are actively attempting to negotiate a deal to prevent a government shutdown on October 1, 2023. Along with many other government agencies, the ability of the Food and Drug...

September 25, 2023
DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)
With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization? Although the FDA has now issued two...

September 27, 2023
ProPharma Appoints Alena Hammond as Global Head of Clinical Operations
Raleigh, NC, September 27, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

September 13, 2023
ProPharma Introduces ClinCHAT, a Solution to Unleash the Power of Real-World Evidence with Conversational AI
Raleigh, NC, September 13, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

August 30, 2023
ProPharma Expands Regulatory Sciences Team in the Japan and Asia-Pacific Region with Addition of Neama Baho
RALEIGH, NC, August 30, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

May 3, 2022
ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook
ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook A Customer-Centric Approach to Clinical Research Solutions ProPharma Group is honored to be named Top 10 CRO 2022 by Pharma Tech Outlook...

April 21, 2022
ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards
ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards: ProPharma Group is honored to be awarded “Best Pharmaceutical Regulatory & Compliance...

June 10, 2022
The Cost of Poor Project Management
Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

August 31, 2022
Successfully Passing MHRA Inspections for Overseas Manufacturing Sites
ProPharma Group offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma Group’s Compliance and Quality team completed the...
News & Insights

September 27, 2023
ProPharma Appoints Alena Hammond as Global Head of Clinical Operations
Raleigh, NC, September 27, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

September 13, 2023
ProPharma Introduces ClinCHAT, a Solution to Unleash the Power of Real-World Evidence with Conversational AI
Raleigh, NC, September 13, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

August 30, 2023
ProPharma Expands Regulatory Sciences Team in the Japan and Asia-Pacific Region with Addition of Neama Baho
RALEIGH, NC, August 30, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

April 21, 2022
ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards
ProPharma Group Named Best Pharmaceutical Regulatory & Compliance Consultancy: 2022 Corporate Excellence Awards: ProPharma Group is honored to be awarded “Best Pharmaceutical Regulatory & Compliance...

Sep 27, 2023 11:57:42 AM
The Impact of a US Government Shutdown on the Food and Drug Administration
U.S. lawmakers are actively attempting to negotiate a deal to prevent a government shutdown on October 1, 2023. Along with many other government agencies, the ability of the Food and Drug...

Sep 25, 2023 4:59:00 PM
DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)
With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization? Although the FDA has now issued two...

October 14, 2021
Accelerate European Market Access with Compliant and Comprehensive MAA Submission
Preparedness for Marketing Authorization Application (MAA) approval ensures an efficient application process and follow-up. Placing a medicinal product in the European market requires a license for...

March 18, 2022
Outsourcing QA - Reduce Time and Expense While Meeting Critical Requirements
There is a tendency for VPCs to rely solely on the QC/QA units within their outsourced CMO to perform quality functions. However, the sponsor organization has the ultimate responsibility for product...

October 14, 2021
Dedicated Project Manager Directs Regulatory Activities Throughout European Economic Area
Learn how a single point of contact oversaw local regulatory affairs activities across all 31 countries of the EEA. You’re developing a drug, biologic, or medical device product. There are a lot of...

September 1, 2022
Webinar: AI-Powered MI Contact Centers: Key Considerations for a Scalable & Global Medical Information Capability
Today's Medical Information (MI) industry is being driven by evolving customer behavior requiring a more rapid, omnichannel, and digital response to customer needs. The expectation for higher...

October 14, 2021
Ensure Successful Acquisitions with Complete and Accurate Regulatory Due Diligence
Ensure you have as much information as possible to thoroughly evaluate the potential investment when acquiring a company or product. When considering the acquisition of a new company or product, it...

October 14, 2021
Ensure Successful Batch Release, Regulatory Compliance with Experienced Qualified Persons
Streamlining a CMO’s manufacturing process helped ensure GMP compliance for EU batch release and USA inspection readiness. A contract manufacturing organization (CMO) needs to have a reliable quality...

September 28, 2023
How a Two-Part NDA Regulatory Strategy Resulted in Submission Success
Developing a New Drug Application (NDA) for submission to the FDA is an extremely complex process and one that can present challenges to even the most seasoned professionals. From ensuring you have...

October 4, 2021
How to Minimize Overdue Deviations: A Multi-Site Process Improvement Approach
A global biopharmaceutical client with multiple sites operating under a Warning Letter from the U.S. Food and Drug Administration (FDA) needed significant cross-functional support to meet remediation...

October 14, 2021
Identify At-Risk Drug Products and Ensure Compliance Before Nitrosamines Deadline
Risk evaluation of products containing chemically synthesized APIs must be done to assess adherence to nitrosamine regulations. Marketing Authorization Holders (MAHs) must perform a risk evaluation...

October 4, 2021
Increased Visibility for Senior Management with Custom PMO Design, Implementation
Time. Regardless of company size and the number of products in your portfolio, time is one thing we could all use more of. However, the more projects you have in your portfolio, the more stretched...

October 14, 2021
Initiating Enrollment for Accelerated COVID-19 Treatment Studies in 6 Days
In May 2020, as the FDA released new guidelines to accelerate the development of novel COVID-19 therapeutics and vaccines, our Clinical Services experts were asked to provide independent Data Safety...

October 14, 2021
MICC Overflow Solution Was Successfully Deployed and Preserved Customer Satisfaction
A routine safety letter to healthcare professionals (HCPs) was misinterpreted by recipients, causing a “recall-like” crisis event for a multinational pharmaceutical client. When a routine safety...

September 28, 2023
Insider Talks - The Journey of ATMPs From the Discovery to Routine GMP Real Life
In the competitive and fast-moving Cell and Gene Therapy (CGT) field, developers face a range of scientific, technical, and regulatory challenges that can quickly become overwhelming and costly. In...

May 19, 2022
Insider Talks - Tips to Adapt to Today’s Auditing Environment, an Auditor’s Perspective
As businesses face the shared global challenges of adapting to new operating models triggered by the recent pandemic, regulated drug and device sponsors, marketing authorization holders, and...

March 25, 2022
Insider Talks - To Decentralize or Not to Decentralize … That is the Question
Having a decentralized approach is critical to ensuring continuity in the face of disaster, and important in meeting your overall enrollment goals while increasing patient diversity. Join us for our...

October 14, 2021
Secure Timely Product Launch by Ensuring GDP Compliance Across Europe
Our client was in the phase of submitting a Marketing Authorization Application (MAA) in the EU and needed to apply for a Wholesale Distribution Authorization (WDA). After application and approval of...

October 14, 2021
Transfer and Manage Clinical Data Provided by Multiple Third-Party Vendors
Managing and sharing large amounts of clinical data provided by a team of ten plus vendors is extremely challenging and requires meticulous attention to detail and expert-level project management to...

October 14, 2021
Understanding Clinical Trial Requirements for Medical Device Label Extensions
After you have developed an FDA-regulated product and obtained marketing approval, you may think your job is done. However, after all the time, effort, money, and so much more that goes into product...

September 28, 2023
What You Need to Know About Regulatory Programs for Expedited Approval
Differentiating between the FDA and EMA's expedited approval pathways can be tricky. Learn the similarities and differences between them to help determine the best option(s) for your product. The...

October 17, 2021
Outsourcing of Medical Information Content Creation: Experience of 100 Clients
The time and effort required to write, review, edit, approve, maintain, distribute, and update Medical Information (MI) documents while retaining an auditable record of the search strategy is a great...

October 4, 2021
Outsourcing Medical Information Services: When to Consider a Dedicated Resource
Outsourcing Medical Information (MI) services can be an effective solution for ensuring the provision of MI services to HCPs and consumers globally. The most cost-effective model for the provision of...

May 3, 2023
Improve Quality & Consistency by Leveraging AI for Trial Master File Classification
Improve Quality and Consistency by Leveraging AI for Trial Master File Classification The whitepaper "Improve Quality and Consistency by Leveraging AI for Trial Master File Classification" addresses...