SMO - SITE MANAGEMENT SERVICES
Conducting a clinical trial is costly and time bound. At Altree, we are sensitive to these realities and work with speed and efficiency to ensure that our client's studies run without a hitch. Our growing database of investigators keen on participating in clinical trials makes it simpler for the client to review and shortlist prospective sites and investigators. Give us a protocol and we will quickly identify investigators who have the patient pool to meet your research goals. We will verify for you site capabilities and infrastructure and assist you in the evaluation process.For sites that require specific study related equipment, we can assist you with the logistics of site infrastructure provisioning. Our comprehensive training brings study teams up to speed on both ICH-GCP as well as the nitty gritty of protocol specific requirements.If your sites lack coordinators we can fill the gap for your site management/coordination needs. Alternately, you may wish to engage us to monitor your sites. We also facilitate integration with IECs and IRBs and ease the process of managing submissions and obtaining acknowledgments and approvals
Site monitoring visits encompass a range of activities, including assessment of enrollment and continuing protocol adherence, review of all relevant source documents, reporting of previously unreported SAEs, and investigation and resolution of outstanding queries.
ALTREE HEALTHCARE's comprehensive site management services include:
- Investigator recruitment, including development of project-specific questionnaires
- Planning and co-ordination of investigator meetings
- Collection and continued review of site regulatory documents
- Development of informed consent template
- Development of study-specific tools
- Ensuring regulatory and protocol compliance by facilitating monitoring visits.
- Qualifying site assessments
- Initiation visits
- Interim monitoring visits
- Close-out visits
- 100% source documentation of trial data