Transform drug development through data-driven design
You want to maximize the value of your molecule, and, with so much at stake, your success depends on smarter program and trial designs. This requires transparent, rapid access to robust data to inform decision-making; objective scientific and operational expertise; a more structured, collaborative approach that considers all relevant perspectives and evaluation of multiple scenarios for confidence in decision making.
Optimized strategic planning and design
Experts powered by Quintiles Infosario®.
Sub-optimal protocols lead to higher costs, delays and across-the-board inefficiencies. Much of this is avoidable, which is why our Clinical Program Design offering relies on our cutting-edge, proprietary technology, Quintiles InfosarioDesign, to enlighten the process by mining our robust data assets. Infosario Design pools and analyzes information from a wide range of sources – including electronic medical records, clinical research data, public data sources, and industry benchmarking data – and then translates it into actionable insights, enabling informed strategic decisions.
With Quintiles Clinical Program Design, you’ll also have access to our world-class medical, scientific, operational, regulatory and commercial experts. Our collaborative, structured design process systematically brings together your experts with ours to define the challenges and opportunities, identify data sets, test assumptions, debate pros and cons, and ultimately optimize your program design for better results.
Our three-stage facilitated process helps your team translate a Target Product Profile (TPP) into a Clinical Development Plan (CDP) and ultimately, one or more final, authored clinical study protocols.
Stage 1: Program Design
Stage 2: Study Optimization
- Preliminary data mining and strategic review of Target Product Profile and medical, scientific, commercial and regulatory material to identify/address gaps and steer study strategy
- Modeling and simulating time, cost, complexity and risk for multiple study design concepts using Quintiles Infosario Design
- Creation of a clinical development plan supported by objective, quantitatively-driven insights
Stage 3: Finalization
- Study-level feasibility assessment using a comprehensive analysis of key parameters to guide and refine strategic recommendations
- Quintiles operations review (if Quintiles is managing the study) considers operational aspects that should be addressed in the study design from the start
- Optimization of schedule of assessments by evaluating relative efficiency and firmly aligning design with the study’s goals
- Authoring of the final clinical study protocol tailored to meet the project’s objectives
Predictable, tangible results
Superior delivery for improved outcomes.
Together, we will position your product for maximum success by:
- Prototyping time, cost, risk, and complexity of multiple study design concepts to help ensure the optimal final protocol to achieve your strategy
- Providing line of sight connectivity between study objectives, end points, and procedures
- Improving understanding of study feasibility
- Improving predictability of enrollment and trial timelines
- Identifying target countries to optimize recruitment and study costs
- Leveraging benchmarks to evaluate design efficiency and control study budgets
Clinical trials that leveraged Quintiles' data-driven approach have experienced a substantial reduction in protocol amendments due to planning, feasibility and enrollment*:
- 83% achieved below-target protocol development cycle time goal (Design Initiation-Protocol Approval = 184 days as reported by KMR)
- 78% achieved below-target site start-up cycle time goal (PA-FPV = 136 days as reported by KMR)
Effective June 1, 2013 sponsor rolled out Infosario Design to phase II – IV studies within the portfolio
*Cardiovascular, Diabetes, Oncology, Autoimmune/Bone & Inflammation, and Neuroscience
By helping you better balance time, cost and risk from the beginning of the study design process, Quintiles can increase your product’s potential for success. Our data-driven approach drives the results you demand and helps get new therapies to patients faster.