Clinical study start-up

Professional study start up is critical to set the tone for the clinical trial succeeding. BELTAS applies project management principles in planning and executing study start-up to ensure trials are on track from the beginning. Issues are identified early on and either dealt with by BELTAS or notified to the sponsor as required.

Agreements, Indemnities and Site Payments

Through our knowledge of local health systems, BELTAS arranges and assists in site clinical trial agreement, insurance, indemnity and budget negotiations. We also track and maintain study payment information where required.

Investigator Meetings

BELTAS organises and runs local investigator meetings for clinical trial sponsors. This includes the logistics required to bring together busy physicians and other staff in a suitable time and location, organising the agenda, assisting the sponsor with materials, training and demonstrations, and handling any follow-up required.

Patient Recruitment and Retention

Finding the required number of patients is one of the greatest challenges facing clinical trials. BELTAS acknowledges that it is of critical importance to sponsors to recruit and retain trial subjects who meet the inclusion criteria.

BELTAS brainstorms, develops and executes effective recruitment strategies to meet sponsor goals, demonstrated by our experience to date. See Case Studies for examples.

Site Initiation & Training

Getting studies off on the right foot is key to their success. BELTAS prepares for site initiations in conjunction with the sponsor and sites. SOP's are supplemented with checklists to ensure sites are prepared well for study start-up. Training and follow-up support from BELTAS staff is provided, with additional training available where required, for example where site personnel change during the study.

Investigational Product Logistics

BELTAS organises the regulatory approvals required for product import, and also arranges shipment, receipt, storage, and distribution to sites through appropriate logistics companies. Product accountability, along with return and/or destruction at the end of studies, is also provided.

 


 

 

"Patient recruitment consumes more time than any other clinical trial activity, with thirty per cent of clinical trial time spent finding and enrolling study subjects"

- Cutting Edge Information