Safety and Medical Management

Our team of skilled professionals has extensive experience in medical management, pharmacovigilance and the regulatory requirements for safety services.

We have a dedicated, medically-qualified staff that is aware of and compliant with all international guidelines and regulatory requirements for monitoring of clinical trial subjects’ safety and for expedited and periodic safety reporting. Our team regularly monitors, verifies and reviews safety parameters in close collaboration with our Customers and relevant DSMBs. This team is also instrumental in the training of Accelsiors' staff and Investigators.

Study specific plans define the exact roles and responsibilities of Accelsiors, our Customers, Investigators and third parties (if applicable). These plans reflect contractual obligations and agreements, and define the applicable regulatory obligations, applicable SOPs and procedures to be followed.

WE ARE CONSCIOUS OF THE IMPORTANCE OF:

• Enrolling eligible subjects:
  • Implementation of Eligibility Verification-Confirmation Process significantly minimizes the risk of enrolling subjects who do not meet all protocol defined eligibility criteria;
• Subjects’ safety throughout clinical trial:
  • Continuous and periodic review of safety data and parameters ensure early identification of potential safety signals and implementation of appropriate actions to handle such signals;
  • Through the 24/7 safety surveillance we are prioritizing subjects’ safety – our experienced medical and pharmacovigilance staff is always available to the Investigators;
• Compliance with local, national and international guidelines (including Good Clinical Practice (ICH-GCP)), as well as regulatory requirements. This includes:
  • An overview of the local and national regulations and guidelines with respect to monitoring and reporting of safety for clinical trials;
  • What should be reported to whom, when and how.

SAFETY AND MEDICAL MANAGEMENT SERVICES:

• Medical Management:
  • Eligibility Verification-Confirmation process;
  • Medical consultations (e.g. eligibility criteria, protocol design, requirements and restrictions);
  • Review and analysis of safety listings and tables;
  • Safety signal detection and analysis;
  • Medical coding.

• Pharmacovigilance:
  • Periodic Safety Reporting (DSUR and periodic line listings);
  • SAE/AE/ADR handling (collection, database entry and evaluation);
  • Identification of AEs of special interest and appropriate handling;
  • Provision of CIOMS and/or MedWatch forms for all SAE reports within expected timelines;
  • Registration with EudraVigilance;
  • Overdose handling (collection, database entry and evaluation);
  • Pregnancy handling (collection, database entry and evaluation);
  • 24/7 safety surveillance - available to Investigators for all PV related questions;
  • Peri-marketing PV services.

• Data Safety Monitoring Board (DSMB) management:
  • Member selection;
  • Charter development;
  • Meeting support and coordination.