Medical Monitoring &
Reporting of Serious Adverse Events
Our Medical Monitoring team consists of therapeutic and clinical experts who are available to provide medical supervision of clinical studies.
We provide consultancy for
• Study design, protocol review, review of CRFs, and the preparation of final study reports, abstracts and manuscripts
• 24-Hours/7-Days medical coverage
• Recruitment of investigational sites
• Review of patient eligibility
• Answering Drug Related/protocol questions
• Medical review of AEs, SAEs and Investigation reports
Patients' safety is given prime importance and Serious Adverse Events are monitored, documented and reported within the defined timelines.
Our Medical and Safety Services team includes Doctors with experience in medical management across a wide array of therapeutic indications.
We are prepared to receive your reports 24/7/365 and we offer dedicated phone and fax lines. We can submit SAE reports in an agreed format to you or directly to the regulatory authorities as applicable and also to the participating sites. Our Doctors review the SAEs forms, narratives and reports to be submitted to Regulatory authorities.
Our Services »
International Collaboration with
X-Lab (S) Pte, Singapore |
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