Medical and Safety Monitoring

  • We enable smooth and harmonized study medical and safety monitoring and management, through knowledgeable, responsive and friendly approach to Site Personnel.
  • We always engage in efficient bidirectional communication between Medical/Safety Representative and Clinical Operation team members thus facilitating uniform decision-making process in a timely manner.

Our medical and safety monitoring coverage is designed to assist You in:

Start-Up Activities through:

  • Protocol and electronic case report forms (eCRFs) development and review.
  • Sites, Investigator/Key Opinion Leaders (KOL) identification.
  • Creation of Medical and Safety Monitoring Plan.
  • Site initiation.
  • Identification of effective enrolment strategies for specific sites.
  • Provision of therapeutic and project-specific training to operational team members and sites.

Our Ongoing Trial Activities include:

  • 24/7 full time service Medical and Safety Monitoring.
  • Motivational calls to investigators and study coordinators throughout trial.
  • Active engagement with clinical research associates (CRAs) and project managers in discussions related to day-to-day patient care.
  • Clarification of medically relevant study conduct issues to clinical operations team members.
  • Assisting the sites regarding accurate screening, inclusion and exclusion of study participants.
  • Assisting the project team on identifying needs for protocol amendments.
  • Collaborating with sponsor medical and pharmacovigilance teams in case of working for a CRO.
  • Reviewing of lab reports, AEs and SAEs, protocol deviations and violations and their respective classification into major or minor.
  • Continuous Medical Management of Clinical Trial Subject Emergencies.

Our Close-out Activities include:

  • Reviewing of Final Tables, Listings & Figures (TLF).
  • AE and SAE review and MedDRA coding.
  • Writing and/or Reviewing of Clinical Study Report (CSR).
  • Strategic evaluation of study outcomes with Sponsor in case our services are provided via a CRO.
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