Regulatory Affairs
Our study management approach is to be proactive and responsive with study sites.
As Project Management is all about real patient data, so our efforts are mostly aligned towards patient recruitment and retention. Project Managers work closely with sponsors to ensure that sponsor requirements are met in compliance with study timelines. Our project management team has been one of the success factors for past and current projects. The project managers are the central point of contact to improve studies’ efficiency and communication.
In addition, the Project Managers work closely with the sites to address potential issues before they occur, or to resolve issues before they escalate, which ensures timely and satisfactory completion of studies.
STUDY STARTUP
Biosite Start-up teams deliver a well-coordinated, collaborative, and customized approach that accelerates site initiation and is critical to every phase of global trials. Working closely with the top therapeutic and regulatory experts, our proficient, experienced, and dedicated team members engage quickly and provide strategic thinking – ensuring quicker start-up times than industry averages.
PATIENT RECRUITMENT & RETENTION
Biosite ensures patient recruitment and retention by providing strategic solutions with our multi-dimensional recruitment model. It enables us to implement innovative, comprehensive, and customized recruitment and retention strategies that identify, recruit and retain members of specific patient populations.
RECRUITMENT & RETENTION TOOLS
- Appropriate Site Selection for Quick Recruitment
- Training of Site Staffs & Clinical Team
- On-time Recruitment
- Referrals
- External Database
- Investigator Networking
