Site Management Services
Site management is an indispensable element of clinical trial execution and ensures clinical trial success. Site management empowers sites to effectively conduct the trial while ensuring regulatory compliance, protocol adherence, subjects rights, safety and wellbeing. An efficient clinical site is essential to complete any clinical trial with optimal compliance and regulatory requirement. Good sites can recruit and retain subjects while adhering to the study protocol and relevant regulatory requirements.
Abiogenesis offers following Site Management services to empower sites to manage multiple studies with highest regulatory compliance and protocol adherence
- Abiogenesis team will help to educate sites before the study start on all the aspects
- We assist the Site in forming the Ethics Committee as per Guidelines and register the Ethics Committee in regulatory body.
- We help sites to Prepare for EC submission and EC Presentation
- We will facilitate and review the enrolment, ensuring regulatory compliance and adherence to the protocol, managing adverse event reporting, remote and on-site monitoring, data collection and ensuring oversight at each clinical research site.
- We will educate sites for clinical trial-related software like IWRS, E-CRF, CTMS, Drugs Supply Management and Storage etc.
- Abiogenesis also supports Sponsor for placement of highly trained Clinical Research Coordinators (CRCs) at research site dedicated to a specific study.
- Our experienced research coordinators are experienced to ensure each trial is conducted with the highest standards of quality and ethics.