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Peer review
paper published
by GAP

Medical writing,
Clinical Expertise,
Technical Development
is our core
competency

Data Safety
Monitoring Board
(DSMB)

DSMB

Clinical
Events
Committee

CEC

Safety
Assessment
Committees

SAC

Message
from
the CEO

President
and
Co-founder

Our
Service
Card

Business
Card

Automated
Remote Data Manage
QC and Medical
Monitoring
Service

Business
Card

We wrote
the book
On
GPV & E

Pharmacovigilance
is
What We Do.

We wrote
the book
On
Immuno-Oncology

Oncology-Clinical
Devlopment
is
What We Do.

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Global Medical Monitoring

Our medical monitors provide the following services at the global level as well as within the MOH's jurisdiction of choice:

ACCOUNTABLE FOR SAFETY ACROSS THE STUDY

Manage SAEs working with the global teams in determining if a follow up action is needed. Participate in Safety Review Team, Data Monitoring Committee (DMC) and steering committees. Answer safety questions and review the literature as needed to address safety issues. Review ICFs from sites with deviations from approved SOP, GMP, etc. Safety communications to sites across the study. DESIGN PROTOCOL AND STRATEGY: Design clinical studies to meet the requirements outlined in the Target Product Profile. Direct a Clinical Scientists in writing the synopsis and protocol including all required elements. Approve protocol and amendments. Approve study template informed consent form. Provide global medical input into country feasibility. Coordinates with the Clinical Scientist to review and approve design deliverable.


STUDY LEVEL DATA REVIEW:

  1. Perform review of data generated by statistical analyses
  2. Request additional tables or analyses where appropriate
  3. Reviews individual data with SAEs and potentially clinically important laboratory test or vital sign abnormalities
  4. Perform all reviews and procedures required for database lock
  5. Reviews all patients narratives

TRIP REPORT ISSUES TRENDING:


-Specific medical/protocol training for RSMs and SMs -Site medical/protocol training for use during SIV


Questions from Sites on Protocol:



Contact us for more information.