Clinical Development Planning

At Precision, we develop custom-tailored solutions that efficiently and effectively address your study’s needs, whether it’s through an adaptive design, basket study, patient stratification, or immune monitoring. By harnessing our comprehensive expertise, you’ll get innovative and cohesive thinking around medical, scientific, operational, statistical, and regulatory considerations that help bring your novel therapies to patients faster.

Clinical Development Planning

At Precision, we develop custom-tailored solutions that efficiently and effectively address your study’s needs, whether it’s through an adaptive design, basket study, patient stratification, or immune monitoring. By harnessing our comprehensive expertise, you’ll get innovative and cohesive thinking around medical, scientific, operational, statistical, and regulatory considerations that help bring your novel therapies to patients faster.

Clinical trial development with Precision

Maximize insight with biomarker-driven studies

Planning is integrated

Cross-functional teams collaborate with you to develop efficient and informative clinical development plans

  • Biostatistics
  • Medical writing
  • Data management
  • Medical & safety monitoring
  • Market access & positioning
  • Specialty labs/Translational sciences
Planning is proactive and comprehensive

With 20+ years of experience running clinical trials, we know what to expect and how to plan for the unexpected.

Because we focus on biomarker-driven studies, we understand how to accommodate and integrate biomarker data to maximize your insights into patient biology.

Case Study: Exceeding enrollment expectations in a rescue study: A phase 3 registrational trial in multiple myeloma

Precision was identified by a sponsor to rescue global and US management of a phase 3 registrational trial in relapsed, refractory multiple myeloma patients. This study targeted the enrollment of 780 patients at 155 sites in 20 countries. The sponsor’s primary motivation for pursuing the shift to Precision from the other contract research organization (CRO) was

based on their recognition that clinical research associates (CRAs) with little to no multiple myeloma experience and only minimal monitoring experience had been placed on their study. Find out how Precision was able to quickly transition onto this study and complete the much-delayed patient enrollment one month early in the full case study.

“We have decades of experience in clinical trials and how to think these through to minimize risks and increase chances of getting approval.”

Gerald Messerschmidt, MD, FACP
Chief Medical Officer

“We have decades of experience in clinical trials and how to think these through to minimize risks and increase chances of getting approval.”

Gerald Messerschmidt, MD, FACP
Chief Medical Officer

Tell us about your project requirements

Our comprehensive biomarker-driven clinical trial expertise is just one of the many reasons to choose Precision for Medicine. See how else we can maximize your inisight into patient biology.

Tell us about your project requirements

Our comprehensive biomarker-driven clinical trial expertise is just one of the many reasons to choose Precision for Medicine. See how else we can maximize your inisight into patient biology.

Related Clinical Trial Services

Global Clinical Trial Footprint

Sample processing labs, clinical trial sites and offices in five continents provide the clinical reach and scale to manage complex global programs.

Clinical Development Strategy

Tailored strategies consider the scientific, regulatory, and commercial factors that shape each trial, mitigating risk and advancing the development pathway.

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.

Biostatistics

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.

Explore other areas of expertise