Feasibility concerns a specific protocol at a specific site, rather than a general introduction to the clinic. The following is an independently prepared discussion checklist, not a regulator’s mandatory form or a statement of Bessalar’s capabilities.
Six parts of an initial brief
| Part | What to include | What to leave as a question |
|---|---|---|
| Objective | Study type, product and purpose of the enquiry | Which activities are requested from the site |
| Documents | Title, version and date of the available protocol or synopsis | Which documents can be shared, and through which channel |
| Participants | Target population, planned number and main criteria | Evidence behind the recruitment estimate and remaining checks |
| Workload | Visits, stays, important procedures and restrictions | Who will confirm resources and external services |
| Samples and data | Analytical laboratory needs and planned transfers | Who defines conditions, receives materials and resolves discrepancies |
| Project plan | Desired start, dependencies and project contact | Which assumptions are provisional and which are documented |
Keep assumptions separate from established facts. An expected recruitment period remains an estimate until the site has assessed criteria, workload and resources. Enquiries are not the same as eligible participants.
What to ask for in the response
Separate the outcome into three parts: activities the site can provisionally consider; questions requiring documents or checks; and conditions that remain unconfirmed. Assign an owner and a next step to each open question.
Compare budgets and schedules against the same scope: periods and visits, procedures, laboratory work, storage, sample transfer and reporting. An incomplete brief cannot support a promise of an exact price or start date.
Starting a discussion with Bessalar
In an enquiry to the clinic, state your sponsor/CRO role and the purpose of the request. Agree confidentiality and a suitable channel before sharing a protocol. Do not submit medical records or named participant lists through the website form.
Continue with feasibility assessment, project stages and site selection questions.
Reference and scope
ICH E6(R3), section 3.7 addresses investigator/site qualifications and adequate resources, and providing the protocol and information for review. Checked on 24 October 2026.
The brief is our practical discussion aid. The international guideline is a reference; determine applicable requirements and responsibilities separately for each project.
Questions and answers
Can we discuss a project before a full protocol is available?
Start with a non-confidential description and a list of unknowns. Agree which documents the site needs for a meaningful assessment. An initial discussion does not confirm timelines, budget or recruitment capacity.
Should we send details of potential participants?
Do not send named participant lists, medical records or participant contact details through the website form for an initial feasibility discussion. Describe the target population and criteria in aggregate.
See also
Feasibility assessment of a clinical study
A feasibility assessment is a review of the protocol before a study starts. It shows whether the study can be run at the site within the required timelines and with the required number of participants. The clinic carries out this assessment for sponsors and contract research organisations (CROs).
Learn more
How to evaluate a clinical study site: questions for sponsors and CROs
Before choosing a site, ask the clinic for documents or data on twelve points — from the right to operate and experience to the quality system, the cold chain, safety, recruitment, data handling and ethics review.
Learn more
Planning biosample handover to an analytical laboratory
Before transferring biosamples, agree the sender, receiver, project documents, inventory, receipt arrangements and discrepancy process. There is no universal temperature: conditions must fit the study and relevant stability evidence.
Learn more