Consulting & Analytics - Clinical Strategy & Planning

Protocol optimization: Pressure test and optimize your inclusion/exclusion criteria to understand precedence and alignment with the latest regulatory guidelines.

• Test inclusion/exclusion criteria for clinical relevance.
• Identify protocol optimization levers.
• Ensure trial design is viable from a recruitment perspective.

Plan for equitable clinical trials: Test diversity plans. Identify key demographic, epidemiological and clinical characteristics relevant to your study population. Assess key trial KPIs to input into trial planning.

Competitive landscape: Understand the competitive landscape and regulatory status for specific drugs, in different countries and indications and which companies were most recently involved in development. Anticipate competitive threats to your programs globally by understanding clinical strategies used by competitors and their likely clinical development.

Enrollment benchmarking: Calculate and graph how long it took trials to enroll and compare treatment durations. Benchmark recruitment rate (pts./site/mo.) for a particular trial set. Snapshot accruals subjects for similar trials by patient segment, disease, or other variables. Calculate and graph the number and average sites for comparable trials.

Patient availability: Identify and assess clinically and demographically relevant protocol-matched patient volumes per country. Compare patient availability with competitive landscape to identify regions with lower competition for patients.

Identify sites and investigators with: Relevant trial experience based on specific protocol requirements, therapeutic considerations, or other study parameters.

• The ability to support a defined age group (adult vs. paediatric vs. geriatric).
• Potential availability based on ongoing trial engagement.
• Recent clinical trial activity.

Prioritise investigators: Using sitetrove proprietary tiering algorithm to highlight, on average and as a group, the investigators with the highest probability of performing well in each disease.

Understand protocol matched patient volumes: Including age, race, and gender demographics to enhance site feasibility analysis and optimize sit and investigator selection.

Ensure your clinical strategy planning moves smoothly and efficiently by employing data-driven approaches to increase the success of your trials. By integrating comprehensive datasets and analytical tools we can ensure your I/E criteria is well defined and aligns with your target patient population, enhancing your recruitment process and trial outcomes. Select geographies with patient populations that accommodate a broad range of patient demographics, provide regulation efficiency, and have the potential for timely completion. Our data-driven site/investigator selection tools can help you evaluate factors such as patient recruitment potential, site performance probability, enrolment rates, and investigators capabilities to enhance efficiency, accelerate timelines, and ultimately deliver innovative therapies to patients in need, faster.