Specialized Safety Services
Clinexel expert physicians and pharmacists provide Specialized Safety Services including early phase safety and medical monitoring of new therapies, development of integrated safety databases, signal identification and management during clinical development, development and implementation of medical and safety monitoring plans
EXPERT SAFETY WRITING SERVICES
- Preparing Responses to Request for Information (RFI) from Competent Authorities
- High Quality Narrative Writing
- Preparing Direct Healthcare Professional (DHCP) Communications
- Analysis of Similar Events (AoSEs)
- Benefit Risk Assessment Reports
- Integrated Safety Summary (ISS)
- Safety Sections of Clinical Trial Reports
- Clinical Overview and Clinical Summary
Drug Safety in Clinical Development
- Highly Experienced and trained Drug Safety Physicians
- Processing & submissions of Serious Adverse Events from Clinical Trials.
- 24/7/365 support by Drug Safety Physicians for Investigators
- High Quality and Cost- Effective Services during all Phases of Clinical Development
- Safety Monitoring Plans
- Medical Monitoring Plans
Study start up activities
- Authoring Safety Sections of Clinical Study Protocols.
- Set-up of Serious Adverse Event Reporting Procedures
- Training of the Investigators and CRAs.
- Preparation of Investigator Serious Adverse Event Manual.
Serious Adverse Event Management
- Initial Event Receipt and Triage.
- Case Processing, Including Data Entry, Narrative Generation, and Quality.
- MedDRA Coding
- Analysis of Similar Events (AOSE)
- Submission of SUSARs to Relevant Regulatory Authorities
- Reconciliation: Periodic Reconciliation of Safety Database with eCRF