Medical and Safety Monitoring

Precision’s pharmacovigilance and other medical services start with a collaborative mindset. This key element of our approach stems from our drive for client success through the following: reducing the burden on the sponsor’s internal medical resources, providing customized project team training and support, and supporting strong site performance through site engagement.

Medical and Safety Monitoring

Precision’s pharmacovigilance and other medical services start with a collaborative mindset. This key element of our approach stems from our drive for client success through the following: reducing the burden on the sponsor’s internal medical resources, providing customized project team training and support, and supporting strong site performance through site engagement.

Medical and safety monitoring for biomarker-driven study success

Project-specific plans, expert physician support

A purpose-built medical team

Medical support is a critical aspect of the planning and execution of any clinical trial. In the setting of trials that are designed around personalized medicine concepts, our clients need medical experts who are intimately familiar with both the clinical context of a study and the science that underlies a particular drug development strategy.

Precision has built a medical team that provides this dual level of support that is so vital to your studies.

Comprehensive medical oversight and support

Precision’s medical monitors are key participants from trial setup, through execution and follow-up, and into end-of-study activities, such as data analysis and trial report preparation. During each stage of a study, our medical monitors engage in the full range of essential study activities.

Precision’s approach to each activity is based on a risk-mitigation strategy:

  • Proactive assessment of potential risks (to subjects and to the study’s objectives)
  • Early identification of emerging challenges
  • Medical support to develop situation-specific interventions

Case Study: Use of flow cytometry data to achieve optimal dose: A phase 1 immunotherapy trial

Throughout this phase 1 immunotherapy trial, the team collected samples to evaluate tumor biomarker expression and activity, as well as the degree and type of immune infiltration by immunohistochemistry. However, until the final cohort was reached without demonstration of adverse events, these were not analyzed in conjunction with the clinical data.

Upon completion of the final planned dosing cohort, the question remained, “Did we achieve the final ‘optimal’ dose for more robust evaluation of efficacy, or were further refinements to dosing needed?” Without clinical evidence, it was necessary to rely on biomarker and immunohistochemistry data for insights.

Tell us about your project requirements

An experienced and customized medical and safety monitoring program is just one of the many reasons to choose Precision for Medicine. Contact us to learn more.

Tell us about your project requirements

An experienced and customized medical and safety monitoring program is just one of the many reasons to choose Precision for Medicine. Contact us to learn more.

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.

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