Medical Affairs 360 has the expertise and experience to perform the following medical and scientific activities for your organization…
PRODUCT STRATEGY
- Medical information and regulatory writing
- Literature surveillance
- Competitive analysis
- Pharmacoeconomics
- Publication plan, poster, and manuscript writing
- Medical and promotional review
DRUG SAFETY ANALYTICS AND PHARMACOVIGILANCE
- Medical case assessment
- Drug safety review and evaluation
- Signal detection and risk management
- Due diligence
- FDA regulatory advisory & support
DEPARTMENT STRATEGY AND PROCESSES
- Business planning
- Product launch strategy
- Policies and Procedures development
- Audits and gap assessment
- Call center strategy
CLINICAL DEVELOPMENT
- Statistical programming
- Medical writing: protocol, investigator’s brochure, ICF
- Clinical trial safety oversight
- CRO selection and oversight
- Safety database selection and implementation