Decentralized Clinical Trials (DCTs)

ProPharma Group 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.

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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

  • Temperature
  • Respirations
  • Blood Pressure
  • Pulse/Pulse Oximetry
  • Weight/Height/BMI

Lab Sample Collection and Processing

  • Blood/Plasma
  • Urine
  • Saliva/Sputum
  • Stool
  • Finger Sticks

IP Logistics

Per Protocol Assessments

Targeted Nursing Assessments

IP Administration

  • Infusion
  • Injection
  • Oral
  • Topical

Telehealth Support

Patient Reported Outcomes/Scales

Patient Training

  • IP Administration
  • Diary Completion
  • Device

Other Safety Assessments

  • Changes in Health Status
  • Concomitant and Treatment Medications
  • ECG

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 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. 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 Group 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 Group’s Decentralized Clinical Trials?

Nursing

ProPharma Group 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 Group 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 Group has 27 offices worldwide spanning six continents, providing a truly global footprint to support your decentralized clinical trials. ProPharma Group 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:

  • Anti-infectives
  • Neuroscience / Neurology
  • Cardiovascular
  • Onco-immunology
  • Central Nervous System
  • Oncology
  • Dermatology
  • Ophthalmology
  • Device and Diagnostics
  • Pulmonary / Respiratory
  • Endocrine / Metabolic
  • Rare and Orphan Diseases
  • Gastrointestinal
  • Rheumatology
  • Immunology
  • Vaccines

Interested in learning more? Contact us to discuss your Decentralized Clinical Trial goals.

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