NexusCRO offers pharmacovigilance solutions for clinical safety, post-market surveillance and risk management or risk minimization plans. Our Medical Affairs team is comprised of experienced clinical professionals who analyze the safety profile of their products throughout all the phases of clinical development and post-marketing.
Our pharmacovigilance management plan describes in detail the safety processes unique to each client. We also provide full database and hosting services that encompass the collection and management of safety data, from database build to validation to international reporting. Clients have the ability to access their safety data remotely, anytime, anywhere and in real-time.
Our Pharmacovigilance Services include:
- Safety Management Planning.
- Clinical Protocol Safety Section Development.
- Protocol review.
- Case record form review / SAE form development.
- Investigator Brochure review.
- SAE collection, evaluation, classification, and reporting.
- Processing of Serious Adverse Event or Unanticipated Adverse Device Effect reports Coding Review .
- Periodic Safety Update Reports (PSURs), Annual Reports or End of Study Reports
- Medical case review.
- Safety database development and maintenance.
- Adverse event narratives and coding.
- Regulatory reporting.
- Setting Up of Global Phamcovigilance Systems as per regulatory requirements .
- Reconciliation Services - Safety/Clinical Databases.
- Regulatory Dictionary Coding - MedDRA, Sponsor Specific.
- Remote access through a secure line.