Expert Feasibility Assessment for over 20 Years
Attentive selection and evaluation of the investigator and site are key to a clinical trial’s success.
Feasibility Assessment is an essential first step before conducting any clinical trial.
Clinical trial feasibility facilitates the process of selecting country, sites and investigators, as well as patient recruitment strategies.
Sponsors contact Dokumeds for specialist regional feasibilities and management of global feasibility studies. We perform extensive qualitative reviews of the information we gather. Open source databases, publications and relationships with key opinion leaders provide valuable information, but nothing replaces information acquired on the ground, confirmed in real time.
Key assessment factors
- Geographical potentiality
- Regulatory related risks
- Patient population to determine capacity and speed of enrollment
- Risks in patient recruitment
- Availability of referral networks
- Investigator/site interest
- Investigator/site experience in conducting clinical trials
- Availability of qualified site personnel
- Availability of equipment/facilities required by to the protocol
- Gap between protocol and standard of care
- Additional sponsor requirements
Clinical trial feasibility is a core initial step for any clinical study
Dokumeds’ specialized feasibility team is led by our medical director, an experienced medical professional skilled in evaluating medical information and study protocols. Regulatory, pharmacovigilance and financial specialists join the team when necessary, and external experts are consulted if needed. Our multifunctional team is responsible for identifying specific countries, sites and investigators in order to develop a strategy to meet enrollment targets and complete your project on time and on budget.
Benefits of feasibility:
Clinical trial feasibilities allow sponsors to determine potential challenges in advance and plan accordingly. They give sponsors and CROs the opportunity to assess a multitude of factors so that your project is initiated and completed efficiently and with minimal risks.
The feasibility process:
The feasibility process begins as soon as a client approaches Dokumeds with a request for proposal for a clinical trial. We evaluate the enrollment and treatment phase from various perspectives — medical, operational, regulatory and logistics, bridging the gap between study protocol and standard of care. This includes clinical trial site feasibility, thoroughly reviewing study design, inclusion/exclusion criteria, patient resources, health care environment and site readiness. Critical analysis of gathered information is particularly important to identify potential site and study related risks.
Dokumeds' Feasibility Group
Dokumeds' Feasibility Process
Practice-based regulatory consulting expertise, and support throughout the product life cycle.
We deliver high-quality solutions, with services designed to ensure patient safety at every stage of the drug life cycle.
Our highly nuanced approach that accounts for the specific needs of each project.
We have a golden track record of meeting recruitment targets for sponsors.