Clinical Development Planning Made Personal
Efficiently and effectively address your unique program needs with custom clinical development plans.
From adaptive designs and basket studies to patient stratification, immune monitoring, and beyond, you can harness Precision’s comprehensive medical, scientific, operational, statistical, and regulatory expertise to propel therapeutic development and shorten your time to patient impact.
Successful clinical trials start with robust planning and comprehensive capabilities, particularly for cell and gene therapy studies, as well as biomarker-driven clinical trials.
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
Target Product Profile (TPP) Creation
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
- Fast-track designation
- Breakthrough designation
- Priority review
- Priority medicine (PRIME)
- Accelerated approval
- Regulatory strategic and operational support for major filings
- Writing and review of CTD modules (IND/CTA/BLA/NDA/MAA)
- Regulatory program management IND/CTA development
- GAP analysis
- Regulatory project plans
- Rare experience
- US and EU Orphan drug applications
- Extensive population experience
- Study and investigation plans
- Pediatric rare disease designation
Case Studies in Clinical Development Planning and Study Optimization
Supporting a Rare Disease Basket Trial
Precision supported a sponsor in planning conversations with their board to support the funding of a rare disease basket trial.
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.
The sponsor had a successful board meeting and is moving forward with IND submission.
BLA Submission Strategy and Planning
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.
Type C meeting request, preparation of the briefing document, and development of the strategy for integrated safety submission (ISS), including CDISC conversion.
The FDA provided written responses that were clear and supportive of the integration approach. This prework 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.
Support for pre-IND meetings and IND filings
Assistance for novel targeted therapies, including antibody-drug conjugates, gene therapy, nanoparticles, and engineered proteins.
Generation and support for meeting requests and meeting packages; assistance with IND.
Introduction of programs to the FDA; input received for IND content expectations; safe-to-proceed assessments for IND submissions.
Improved Market Access
As payer evaluation criteria continuously evolve, ensuring optimal access is an ever-present challenge, thus making early market access strategies essential to your program’s success.
Precision strategists and policy professionals can guide your next project’s development through the evolving 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
Precision’s Market Access Services
Value Study Development
Start your journey to approval today
Related Clinical Trial Services
Global CRO Capabilities
Clinical trial sites and offices on 5 continents, alongside specialty and sample processing labs, provide the clinical reach and scale necessary to manage complex global programs.
Clinical Trial Design
Advanced trial-design approaches– including basket, umbrella, and adaptive trials– deliver biomarker driven clinical research. Deep experience in these highly complex trial designs maximizes both insights and efficiency.
Seasoned biostatisticians and statistical programmers deliver insight into every trial phase, from study design to regulatory submissions, all backed by meticulous documentation and data monitoring.
Clinical Sample Management
Sample inventories from a global network of labs supply real-time processing in 55 countries; consolidated data from central labs, screening labs, and specialty labs with clinical data create actionable reports.