Therapeutic expertise2019-11-04T16:41:16-04:00

Deep, specialized knowledge and a passion for the patient

Oncology and rare diseases create novel regulatory and operational challenges. Precision provides an end-to-end solution. We start with highly specialized disease-specific experts in regulatory and clinical development, integrate biomarker endpoints and specialty labs, and deliver through a global footprint to rapidly identify the right sites and targeted patient population. Above all, we bring a passion for helping patients find promising therapies—and for eradicating cancers and rare diseases.
Every trial is unique. So, our flexible, personalized approach adjusts to client and patient needs. Because each trial has a dedicated team—and each team brings deep experience—we are able to provide the unique support small and virtual biopharma groups need, while remaining equally focused on helping patients and their families.
With our extensive presence across Europe and North America, we can extend that personalized approach to multiple geographies, coordinating every aspect of regulatory communications, drawing on years of cross-country and cross-cultural experience to ensure your strategy is sound and the submission is easily reviewed and structured by regulators, maximizing the likelihood of global approval.
Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level, using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. The result: Robust insights that inform real-time decisions—and optimize the oncology development pathway.
Accelerated pathway to proof of concept. Our novel approach of integrating clinical development, specialty assays, and biomarker data management and analytics enhances the predictability of achieving study goals and obtaining objective data to inform future development decisions.

Highly experienced oncology team spanning every resource level. We have a team of seasoned and well-retained oncology experts who are dedicated to advancing oncology research and therapeutics—expertise that extends to every person who works on your trial.

Oncology Site Network for predictable start-up and performance. You want your trial to hit your first milestone; that begins by selecting the right sites. Our specialized network of qualified oncology sites carefully aligns site capabilities to protocol requirements. Each site brings expertise in all phases and indications of oncology trials, backed by a commitment to expedited study start-up and quality processes—and a track record of success.

Deep engagement from seasoned oncology CRAs. Clinical research associates (CRAs) are perhaps the most critical resource on your trial. That’s why Precision takes great care in hiring the most seasoned CRAs. With a 95% retention rate, we work hard to retain them, too. While larger CROs assign CRAs 4–5 trials at a time, our CRAs embed themselves in just 1 or 2 trials. They stay with you through every phase of the trial, becoming specialists in your trial and ambassadors of your sites, understanding your protocol, mitigating challenges—and, ultimately, ensuring the delivery of quality patient data.

Match the right patient to the right drug

Integrating hands-on oncology-specific clinical expertise with real-time biomarker data analysis helps accelerate complex trials. Patricia Devitt Risse, President, Oncology, explains.

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Broad Therapeutic, Drug Class and Study Design Expertise
Deep, specialized experience in oncology
We target well-defined patient populations and sites experienced in precision medicine trials.
Rare disease trials target small patient populations spread over a wide geographic area. The regulatory hurdles, coordination challenges, and cultural barriers that come with the territory are why you need an experienced team. Our specialized expertise and global footprint—paired with scientific excellence and multifaceted knowledge of everything from protocol development to regulatory affairs to biostatistics—make us uniquely qualified to help you stay ahead of the issues, so you can achieve your clinical development goals rapidly.
Expertise grounded in deep science. Our unparalleled knowledge spans over 50 rare and orphan diseases. It is paired with in-house biomarker and specialty lab services that refine trial targets and speed results, with deep expertise in adaptive clinical trials, basket studies, and early phase rare disease trials, and a customized approach to every nuance from trial design to commercialization.

A uniquely patient-centric methodology. When your study is focused on a small, highly targeted population, every patient is critical. We use our deep understanding of the patient and family mindset to address each individual need and concern, so patients stay in your trial and follow your protocols.

The regulatory skill to expedite your orphan drug designation. It takes a deep knowledge of the precise proof points regulators require—and how to establish clinical verification of those parameters—to streamline the ODD process. Our track record of 100% data acceptance across all orphan projects speaks for itself.

A pioneering technique that addresses the complex challenges of rare disease clinical trials. By working with patient advocacy groups and key opinion leaders, we ensure that trial protocols are realistic given any limitations of the target patient population; use advanced biostatistical approaches to address the realities of rare diseases; define prevalence at country and site levels; and apply our specialized knowledge to identify, recruit, screen, and monitor patients across a wide geography. Maybe that’s why we’ve won the ROAR Awards “Best Orphan Drug CRO” for 2 consecutive years.

Deep knowledge of biostatistics for rare and orphan disease research. With far smaller population sizes, rare disease clinical trials produce limited evidence relative to traditional clinical trials, affecting both trial design and statistical approaches. Superlative biostatistical data management and analytic expertise enables us to support your protocol review and study design, sample size determination, endpoint selection, randomization schedules, outcomes measures and other critical study aspects—serving as your biostatistical analysis partner.

Unparalleled education of healthcare providers, patients, and caregivers to get the right medicine to the right person. We efficiently build awareness and understanding of your rare disease among the full spectrum of interested parties, supporting short-term patient recruitment and developing long-term product demand.

Rare diseases require specialized approaches to trial design and conduct

Our patient-focused approach helps boost trial enrollment and retention, which are critical to success. Ellen Morgan, President, Rare Disease explains.

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Unparalleled expertise in rare and orphan disease

Proud winner of Best Orphan Drug CRO ROAR Awards, for 2 consecutive years.

Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, adaptive clinical trial execution to regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.

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