Consulting & Analytics - Clinical Strategy & Planning

In-depth trial feasibility assessments requires meticulous time and resources to source and collate all the data you need to create accurate analyses and develop actionable insights critical to your business success. Without this painstaking time and effort and access to the right clinical intelligence you risk rushed or inaccurate decisions, affecting your clinical trial timeline and substantially increasing your costs. 80% of all clinical trials fail to run on time. The financial implications on businesses can be huge, with 94% of trials delayed by over a month and costing businesses up to $8million in lost revenue each day.

Consultant working on documents related to clinical strategy and planning

Fast-track your trial feasibility

Mitigate the risk of enrolment delays and plan your trials with confidence. Leverage the power of our industry-leading consultants and data-driven solutions to optimize and accelerate your clinical trial strategy and planning journey.

How it helps

The Citeline Consulting & Analytics team have developed a robust set of capabilities to support clinical teams with their clinical strategy and planning activities. Using our industry experts and our market-leading products like Trialtrove and Sitetrove, along with our real-world data (RWD) solutions, Lab and SDOH, we can help you enhance your trial feasibility with country, investigator, site, and protocol selection and optimization.

How we help

Our team of industry experts apply a strategic approach to validate, benchmark, and refine your data to assess trial feasibility and provide reliable recommendations for sites and investigators to run your trial successfully. We also monitor the competitive landscape and benchmark trial timings to track your strategic objectives and measure successful outcomes.

Partner with Consulting & Analytics for:

Site & Investigator Identification
Diversity Planning
Protocol Optimization
Country/Site Prioritization

Partner with Consulting & Analytics for

Protocol Feasibility

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.

Country Feasibility

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.

Site & Investigator Feasibility

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.

Move Your clinical strategy forward with ease and speed

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.

Case Studies

How we've helped others

Clinical

Rare Disease Prioritization Model and Landscape Analysis

Leveraging Citeline’s proprietary datasets, our Consulting & Analytics team created a weighted prioritization model to assess each rare disease across multiple areas.

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Our experts

With a team of more than 70 consultants globally, extensive data assets, and experience across therapy areas and modalities, we bring deep expertise and tech-enabled solutions to efficiently deliver accurate and actionable insights. We work collaboratively with our clients to provide bespoke solutions to support your business challenge and create a world where innovative treatments reach more patients – faster.