Medical Monitoring & Pharmacovigilance

Safeguarding the well-being of study participants and ensuring scientific integrity of clinical trial data

Medical Monitoring & Pharmacovigilance

Safeguarding the well-being of study participants and ensuring scientific integrity of clinical trial data

Safeguarding the well-being of study participants and to ensuring scientific integrity of clinical trial data is the one of the most important aspects when conducting studies. We support each clinical trial, regardless of phase, with data and safety monitoring procedures in place.

Exom Group’s global pharmacovigilance services give clients access to a dedicated team, customized to the specific project needs to help you respond to increasing regulatory pressures.

Our global reach, quality system approach, and leading technology for SAE and AE case management and reporting to EudraVigilance and FDA, combined with a multi-disciplinary safety expertise offers true value and key benefits to pharma, biotech and device companies.

Genius VIGILANCE™ offers timely and accurate safety reporting, which is critically important in clinical research. In addition to ensuring safety of clinical trial participants, systematic capture and analysis of safety data from clinical trials is important for developing the safety profile of the drug and contributing to its benefit-risk assessment, which is a key consideration in the approval decision.

Genius VIGILANCE™ allows for the automatic transfer of specific data from Genius eCRF™ to the corresponding eSAE report so that the physician can meet his statutory reporting duties with just a few clicks. The sponsor receives high-quality and complete data and needs to spend less time on the follow-up (FU).

Genius VIGILANCE™ eSAE reporting solution offers the main benefits

  • Entered SAE data as well as other relevant information from other areas of Genius eCRF™ (e.g., demography, medical history, concomitant medications…) are sent directly to the Pharmacovigilance (PV) department in the form of a PDF SAE Form
  • eSAE report form could be customized to Sponsor’s template
  • Study sites no longer have to fill out forms twice (paper SAE, eSAE form)
  • The sites’ motivation to fill out the eSAE form correctly increases, as does the completeness and data quality of the SAE reports

  • Immediate mail notification of a new eSAE report availability
  • Regular reconciliation and alignment between the safety database and the study AE database
  • Faster case processing timelines
  • Electronic submission of ICRS XML reports to EudraVigilance and FDA according to ICH E2B (R3) message standard
  • Automated generation of CIOMS and MedWatch forms
  • MedDRA and WHO dictionaries coding availability
  • Entered SAE data as well as other relevant information from other areas of Genius eCRF™ (e.g., demography, medical history, concomitant medications…) are sent directly to the Pharmacovigilance (PV) department in the form of a PDF SAE Form
  • eSAE report form could be customized to Sponsor’s template
  • Study sites no longer have to fill out forms twice (paper SAE, eSAE form)
  • The sites’ motivation to fill out the eSAE form correctly increases, as does the completeness and data quality of the SAE reports
  • Immediate mail notification of a new eSAE report availability
  • Regular reconciliation and alignment between the safety database and the study AE database
  • Faster case processing timelines
  • Electronic submission of ICRS XML reports to EudraVigilance and FDA according to ICH E2B (R3) message standard
  • Automated generation of CIOMS and MedWatch forms
  • MedDRA and WHO dictionaries coding availability

Corporate Vision MagazineAward Winner

Exom is proud to announce that Corporate Vision Magazine has awarded us the 2021 Corporate Excellence Award as "Most innovative Full-Service CRO" for our technology-driven approach to clinical trial management.

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