Following the request from a sponsor or CRO to identify a potential research site or principal investigator with the required medical expertise to conduct a clinical trial, BNCA will assess potential candidates from its own database of diverse sites or from prospective PIs, with regards to their willingness, expertise, and availability of relevant patient cohorts. Site initiation also includes IRB submission, creation of regulatory guidelines and source documents (that contain procedures and guidelines to be followed by the site). Once study is completed, close out visits are performed to ensure proper completion of study according to guidelines and that a thorough review and record retention has been done.
2. Contract/budget negotiations:
Once the site is selected and the sponsor conveys their interest in conducting the trial, the budget for the trial is communicated to the SMO and the costs for various activities which might include the site initiation/closeout fees, patients visits, medical procedures, salary of study coordinator etc., will be negotiated between the SMO and the sponsor. Contracts with various personnel will be drawn up and PI / research site will be recruited for the study on a contract basis for a specific time. Overheads to cover the SMO administrative and travel expenses will be added, which is usually 20% of the total budgeted costs.
3. Patient recruitment/screening/retention
This function includes recruitment through advertising, screening patients for the specific disease of problem under study, designing and drawing up consent forms for patients to sign. Visits and patient screening by site is monitored on a regular basis. Transportation requirements for certain patients have to be arranged. Ensure patient participation and adherence to all guidelines and regulations.
4. Compliance / monitoring
Monitors will ensure that the site follow protocols, keep proper records, informed consent forms, report adverse events to sponsors in a timely manner, account for disposition of study drugs, and any other sponsor requirements. Our team of experienced clinical administrators and monitors, who are usually certified nurses with years of monitoring or auditing experience between them will ensure that trials at clinical sites meet required guidelines and regulations and also to ensure oversight of all aspects of patient health and safety and compliance of accepted GCPs at the research site. Due to conflicts of interest, our monitors will not monitor research trials conducted by BNCA, but instead will be available to other clinical organizations for their monitoring purposes. Monitoring at our site will be performed by our partnerorganization M/S Maneli and Co, or monitors hired by our sponsors.
5. Document archival and maintenance
A safe locked area to maintain records have to be arranged at the site or off site after the completion of the trial. Once the study is completed, arrangements with the PI must be made for archival and storage of study documents for as long as the sponsor requires for which a fee may be charged from the sponsor. Documents will be stored under appropriate conditions as required by federal regulations and GCP guidelines for document storage
6. Financial management:
Our managers serve as the main point of contact for our principal investigators and all financial transactions are shuttled through us. Invoices, patient reimbursement and charges for various procedures and medical screenings of patients by the PI will be processed by our experienced personnel. Reimbursements from sponsor will be tracked periodically and transferred back to the research sites