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Decentralized Clinical Trials (DCTs)

Reduce patient burden while increasing patient recruitment, retention, and inclusion.

While improving flexibility for the patient and expanding geographical reach, DCTs have proven to enhance the patient experience and provide Sponsors with reliable data. This type of clinical trial 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.

The Truth 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 trial’s success. Let our team of experts review your protocol or draft synopsis and consult with your team on what visits/studies could benefit from a DCT model.

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.

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 – sites are still heavily 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.
  • Virtual – patients are never required to go to a site for study visits, all visits take place at an alternate location

Most Sponsors are adopting a Hybrid model, but our team is able to support both Hybrid and Virtual 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 in order to implement a DCT model.

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.

Technology

GoClinical, our proprietary 21 CFR Part 11 compliant technology platform, allows the collection of source data at decentralized visits and electronically sends it to the site 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. 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.

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 DCT goals.

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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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