PLUG and PLAY Model: Strategic Consulting Services
Our Strategic Consulting services are an integral part of our SPEO Model which is designed or tailored to provide unique solutions to our clients on their drug development needs as well as empowering them with the right functional expertise to drive their current needs.
Our SPEO Model also helps quick scale up as the project scope changes and will play an integral in your company scale up process.
The PAR Clinical Team is seasoned in strategically managing clinical programs and can support creating Target Product Profiles, Asset Prioritization, and structuring your program to enable rational and timely decisions to reduce time to market.
Clinical Development Strategy
- Review of pre-clinical package and perform gap analysis. Program manage pre-clinical vendors to support continued pre-clinical package development.
- Build clinical development strategies to optimize and expedite time to market. Develop CDPs, TPPs, Study Design and planning.
- Asset Prioritization.
- KOL engagement
- Functional Consultants to support clinical development :Pharmacologist, DMPK, Translational Meds, Toxicologist, Analytical Chemist
Regulatory Strategy, Affairs and Operations
- Data Package evaluation, GAP Analysis and develop robust submission strategies. Briefing document development, Regulatory meeting prep, representative services
- Regulatory strategic and operational support for major findings.
- Writing and review of CTD modules (IND/CTA/BLA/ANDA)
- Publishing of IND/CTA/BLAs/NDAs
Clinical Program Management and Development Operations
- Life Cycle management and strategy building.
- Oversee the entire development lifecycle from pre-clinical package development to clinical execution.
- Regulatory program management IND/CTA development.
- Risk Mitigation and periodic Risk reevaluation.
- As part the Oversight model (FSP), provide sponsor oversight from IND to Clinical Studies
- Implementation of BIMO elements into clinical trial and project management
- Infrastructure development to support scale up activities
GXP Quality
- Perform GMP, GCP and GPV audits
- Inspection Readiness Activities
- Build GXP Quality Systems