Capabilities: WHAT WE DO!
From preclinical studies to post-marketing, Our Consultants will function as your expert managing all aspects of the project needed. Whether you need a seasoned executive/SME to manage your need we can work within your organization to support you.
Our consultants are flexible, work on a part time, per diem or full time basis.
Below is a small sample!
- Vendor management: Oversight of your PV vendor to ensure they are doing their job as contracted.
- Operations: Clinical, Quality, Pharmacovigilance, Regulatory, Strategy.
- RFP Creation/Contracts: Assist you in contract negotiations with a contract research organization (CRO), vendor selection for PV services. RFP Creation through to vendor set up.
- Case Processors: Drug safety associates to enter your adverse events into your systems or work with your current team in quality oversight of your CRO case processing team.
- Strategy: Develop and grow your PV/ Drug safety department.
- Quality Compliance: Qualified professionals for prequalification audits, gap analysis, SOPs, and submission prep.
- Systems and Guidelines: SOP creation and maintenance of operating procedures. Migration of safety data, Implementation of safety databases such as Argus, ARIS-g. Regulatory strategy, strategic guidance in your overall organization, etc.
- Special Projects: Data checks, Migrations, Legacy case entry, Operational issues, Medical information (Partner), Legal (Partner), vetting the right candidates for your company, SOPs, commercial strategy (Partner), Communications expertise (Partner) etc. We have partners who we work with on special projects who are seasoned and hand-picked by our leadership.