Decentralized Clinical Trials: Services & Capabilities
For a successful decentralized clinical trial, you need a cross-functional team that understands the nuances of remote or hybrid studies. PharPoint’s team comes armed with experience, innovation, and processes to facilitate the flow of study information.
Leveraging proactive operational strategy
PharPoint has proven processes in place to successfully support DCTs. These include:
- Foundational procedures and processes to mitigate DCT study complexities
- A nuanced approach taking into consideration local laws, technological uptake, and population
- Early evaluation of cross-functional input to reduce and plan around DCT study obstacles
- Experience identifying and managing sites capable of supporting decentralized conduct, including the ability to remotely support virtual site qualification, initiation, routine monitoring, closeout visits, and offer site training if necessary
- Ability to integrate, clean, and analyze increasing amounts of data from an expanding variety of data sources
An innovative, client-centric team
PharPoint’s team is focused on ensuring your success, keeping you ahead of study challenges and deadlines. Whether it’s through public health crises or recruitment obstacles, our team is here to support your decentralized or virtual study:
- Experience supporting decentralized/virtual/hybrid clinical trials
- Clinical operations leadership averaging over two decades of industry experience
- Excellence in project management
- Ability to facilitate the flow of study information from disparate sources into a clinical database
Utilizing technology-based solutions
PharPoint leverages numerous industry-best technology solutions to support faster, more cost-efficient clinical research. These solutions include:
- Access to tools that enable holistic review of proposed modalities to determine appropriate decentralized clinical trial processes for a range of therapeutic areas
- Access to comprehensive data and analysis of clinical trial sites and investigators to evaluate sites with the ideal experience and qualifications
- Utilization of integrated virtual study platform for investigation teams and subjects
- Access to patient services that expand study reach and access, increasing recruitment speed
- Utilization of real-time data collection tools to accelerate access to data
What is a decentralized clinical trial (DCT)?
Decentralized clinical trials, or DCTs, are clinical trials where some or all trial-related activities take place at locations remote from the investigator, utilizing telemedicine, mobile/local healthcare providers, and/or mobile technologies.
Subjects visit the clinical site to complete all procedures and assessments.
Some studies may be able to be completed with minimum physical contact with a clinician.
In this approach, subject visits may be conducted using a combination of tools such as electronic Patient Reported Outcomes (ePRO) and electronic Clinician Reported Outcomes (eClinRO), with interaction via telemedicine to complete clinician-directed assessments.
Procedures usually requiring a clinic visit (e.g., vital signs, ECG, Spirometry, etc.) may be completed using wearables or peripheral devices linked to a user interface (usually an app). Subjects may have in-home visits by a clinician for specific protocol-mandated procedures, such as phlebotomy.
Studies have proven that use of virtual subject visits enhance retention rates on clinical trials.
Any combination of the different study designs.
We can leverage relationships with our strategic partners to provide a nimble response to a variety of project needs utilizing a combination of virtual and traditional approaches.