Clinical Development Planning
Custom clinical development planning for global success, with Precision
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Precision partners with you to meet them head-on through our extensive footprint across the globe. We succeed by pairing personalized clinical services with translational medicine excellence, making us the first fully integrated clinical research organization created expressly to help advance the promises of precision medicine.
Robust planning and comprehensive capabilities
Clinical trials approaches are increasingly sophisticated. Whether you are developing an advanced cell or gene therapy, leveraging biomarker data, or looking to achieve an ambitious milestone, success depends on the right approach to match your goals.
Precision’s capabilities in clinical development planning
Clinical development plan (CDP) design
The CDP is the blueprint of a drug’s entire clinical research strategy. It outlines the clinical program design, including development, assessment, decision points, personnel, and budgetary estimates.
Leveraging Precision’s comprehensive expertise in biomarker-driven studies allows you to confidently meet the needs of your project, bringing you closer to your desired endpoints.
- Innovative trial designs
- Review of preclinical and/or clinical data
- Assessment of mechanisms of action
- Proposed patient population(s)
- Proposed dosing
- Safety and efficacy data
- Competitive landscape
- Proposed synopsis(es)
- Associated timelines and budget
Creating your Target Product Profile (TPP)
A TPP outlines the desired characteristics of a product. This includes intended use, target populations, and safety and efficacy characteristics, among other criteria. Alongside Precision’s experts, you can analyze your unique criteria, prepare for best- and worst-case events, and catch the attention of the right funders and developers.
Submission strategy and regulatory support
Pass through regulatory processes the first time with robust submission support for IND, NDA, MAA, and BLA to establish the regulatory pathway. Regulatory strategic and operational support for major filings includes writing and review of CTD modules, as well as viability assessments for expedited or pediatric programs.
For example, recent pre-IND oncology filings and IND package support based on FDA feedback included:
- Targeted nanoparticle with payload
- Targeted fusion protein T-cell receptor/cytokine
- Targeted antibody-drug conjugate
- Vaccine with mutation-specific peptide and oncolytic virus
- Antibody designed to alter targeting of cytokine to specific cell types
- Small molecule oncolytics
Precision's regulatory strategy
Regulatory Authority Meetings
- Question development
- Briefing document development
- Meeting preparation support
- Representative services
Regulatory Submission
- Regulatory strategic and operational support for major filings
- Writing and review of CTD modules (IND/CTA/BLA/NDA/MAA)
Orphan Designation
- Rare experience
- US and EU Orphan drug application
Expedited Programs
- Fast-track designation
- Breakthrough designation
- Priority review
- Priority medicine (PRIME)
- Accelerated approval
Program Management
- Regulatory program management IND/CTA development
- Gap analysis
- Regulatory project plans
Pediatric Planning
- Extensive population experience
- Study and investigation plans
- Pediatric rare disease designation
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Case study showcase: Clinical development planning and study optimization
Recent CDP case studies (click arrows to view):
- Supporting a rare disease basket trial
- BLA submission strategy and planning
- Support for pre-IND meetings and IND filings
- Supporting a rare disease basket trial
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Case study: Supporting a rare disease basket trial
Contracted services
Precision supported a sponsor in planning conversations with their board to support the funding of a rare disease basket trial.
Deliverables
A white paper supporting a basket study combined medical, regulatory, and statistical considerations. From that white paper, a slide deck summarizing the recommendations and alternative scenarios was developed.
Outcomes
The sponsor had a successful board meeting and is moving forward with IND submission.
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Case study: BLA submission strategy and planning
Contracted services
Precision’s regulatory and statistical teams supported a recent oncology study, which is planned to move to BLA submission upon unblinding of the pivotal trial.
Deliverables
Type C meeting request, preparation of the briefing document, and development of the strategy for integrated safety submission (ISS), including CDISC conversion.
Outcomes
The FDA provided written responses that were clear and supportive of the integration approach. This pre-work helped to set the foundation for the ISS strategy, inclusive of statistical, regulatory, and medical writing support for modules 2.5, 2.7.3, and 2.7.4 and all supporting documentation.
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Case study: Support for pre-IND meetings and IND filings
Contracted services
Assistance for novel targeted therapies, including antibody-drug conjugates, gene therapy, nanoparticles, and engineered proteins.
Deliverables
Generation and support for meeting requests and meeting packages; assistance with IND.
Outcomes
Introduction of programs to the FDA; input received for IND content expectations; safe-to-proceed assessments for IND submissions.
Improving market access
Payer evaluation criteria continuously evolve, making strategies for early market access essential to your program’s success. Precision strategists and policy professionals guide you through development and along the regulatory pathway:
- Early health economic modeling to inform randomized control trial (RCT) data collection to support economic value demonstration to payers and health technology assessments (HTAs)
- Payer evidence planning to inform RCT data collection and that meets payers’ needs, reducing coverage restrictions
- KOL mapping to identify sites and shape engagement strategy
- Patient engagement programs
- Scientific platform development
Read our latest Precision insights
Stay ahead with the latest insights in clinical development planning for global product launches, from our experts.
Safety isn’t a Milestone but a Mindset in Clinical Research
Specialized capabilities in every stage of clinical development
Leverage an integrated infrastructure that reduces the inefficiencies inherent in complex development. Integrate lab and trial execution to increase speed to market. Incorporate manufacturing expertise for advances therapies to ensure scalability. Precision can customize and converge our capabilities for your program's unique needs.
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Partnering on your journey to approval
Discover how clinical development planning with Precision for Medicine, can transform clinical trial outcomes.