Whether your IMP is safe and effective to go to the next phase of clinical development or to being marketed is a crucial question for you, your scientific community, patient community, investors, strategic partners and Competent Authorities of your target markets.

Accelsiors Feasibility Unit provides a vital input to your decision making: whether based on a given protocol version your crucial question can be answered and with what timeline and budget. In close cooperation with you, Accelsiors Regulatory, Medical and Proposals we base our feasibility assessment on scientific and clinical considerations, data mining of internal and external feasibility databases and a real-time empirical research and re-confirmation of the capabilities and patient pools of Accelsiors investigator sites.

WE ARE CONSCIOUS OF THE IMPORTANCE OF:

• laying down the foundation of success of your clinical trial by our thorough, unique feasibility approach
• offering our established investigational site network for you, and re-confirming their patient pool and enrollment potential for your study protocol

• inclusion of some additional less sought-after sites to filter out and pick the best who can outperform and join our top performer site network
• critically evaluating and assessing every Feasibility Questionnaire and conservatively re-assessing the patient pool and enrollment potential of each site
• obtaining feedback, and constructive input about the protocol inclusion/exclusion criteria and study design from the investigators as well as from Accelsiors medical experts and ring of external Key Opinion Leaders in the given therapeutic field
• obtaining feedback from Competent Authorities and IRB / ECs about the protocol, and the planned recruitment, logistics, financial, data protection settings of the study
• providing you with feasibility and recruitment options based on different number and mix of countries and sites, protocol and study settings resulting in different CA and IRB / EC approval, recruitment completion timeline, and study budget scenarios
• helping you to leverage our comprehensive feasibility input to develop, refine and finalize your protocol, as an important step forward in your clinical development journey towards delivering your drug to the patients

FEASIBILITY & STUDY START-UP SERVICES:

• Confidentiality Agreement (CDA) development
• Investigator Briefing Package and Feasibility Questionnaire (FQ) development
• Accelsiors Feasibility Database search and initial selection of sites for the feasibility study
• Obtaining executed CDAs and completed FQs
• Conservative re-assessment of sites’ patient pools and enrollment projections

• Assessment of regulatory feasibility
• Feasibility Report writing
• IRB/IEC and Competent Authorities approval
• Site’s contracts and investigator’s fees set up, negotiation and execution
• Translations
• Import/Export License management
• Insurances

Learn more about our comprehensive clinical development services

Accelsiors offers a complete range of expertise in support of your specific needs: Scientific, analytical and regulatory complemented by global resources, state-of-the-art technologies and project management methodology for the most effective execution of your development program across all phases of clinical drug development.

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Medical & Scientific affairs

Data Science

Regulatory Affairs

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Late Phase Development Solutions

Clinical development services