Our Services
Medical Affairs 360 delivers expert support in clinical development, drug safety, and medical affairs strategy. We help pharmaceutical and biotech companies bring therapies to market with confidence and compliance.
Our Product Strategy services help pharmaceutical and biotechnology companies navigate the complexities of drug development and commercialization. From literature surveillance and competitive product analysis to pharmacoeconomic evaluations and publication planning, Medical Affairs 360 provides evidence-based insights that support smarter product decisions.
PRODUCT STRATEGY
WHAT WE’LL DO FOR YOU
+ Medical Information and Drug Intelligence
+ Literature Search Strategy and Surveillance
+ Competitive Product Analysis
+ Pharmacoeconomic Evaluation
+ Formulary Dossier Preparation
+ Publication Planning
+ Scientific Poster and Manuscript Writing
+ Product Launch Strategy
SEND US A LINE TO LEARN MORE
DRUG SAFETY ANALYTICS
& PHARMACOVIGILANCE
WHAT WE’LL DO FOR YOU
+ Medical Case Assessment
+ Drug Safety Review and Evaluation
+ Signal Detection and Risk Managment
+ Safety Oversight Committee Establishment and Governance
+ Due Diligence
+ Safety Database Selection and Implementation
SEND US A LINE TO LEARN MORE
Our Department Strategy services support pharmaceutical and biotechnology companies with everything from department strategy and setup, to developing comprehensive standard operating procedures, to ensuring product launch readiness.
DEPARTMENT STRATEGY
WHAT WE’LL DO FOR YOU
+ Business Department Planning
+ Product Launch Strategy and Implementation
+ Policies and Procedures Development
+ Audit and Gap Assessment
+ Call Center Strategy
+ Training & Development
SEND US A LINE TO LEARN MORE
Our Clinical Development services support pharmaceutical and biotechnology companies with everything from medical writing for clinical documents, to clinical trial oversight and FDA regulatory advisory and support.
CLINICAL DEVELOPMENT
WHAT WE’LL DO FOR YOU
+ Medical Writing: Protocol, Investigator’s Brochure, ICF
+ CRO Selection and Oversight
+ Clinical Trial Safety Oversight
+ FDA Regulatory Advisory and Support
+ Key Opinion Leader (KOL) Development
+ Statistical Programming
- Patient profile and demographics
- Data review listings
- Efficacy and safety review listings
- Survival analysis
- Validation of CRO results (serve as a Sponsor’s statistical representative)
- Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM), and adhoc dataset programming
- Data Monitoring Committee / Data Safety Monitoring Committee analysis
- CSR tables and listing production
- Exploratory analysis
- Analysis support for Publications