Therapeutic expertise2018-07-31T13:34:42+00:00
THERAPEUTIC EXPERTISE »

Deep, specialized knowledge and a passion for the patient

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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.
We extend that personalized approach to regulatory strategy, coordinating every aspect of regulatory communications, drawing on years of experience to ensure the strategy is sound and the submission is easily reviewed and structured by regulators, to maximize 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
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Unparalleled experience in oncology
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We target well-defined patient populations and sites experienced in precision medicine trials.
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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.
A uniquely patient-centric approach. When your study is focused on a small, highly targeted population, every patient is critical. We take a hands-on approach, addressing the needs and concerns of every individual patient to make sure that they stay in the trial and follow the protocols, maximizing recruitment, retention—and outcome success.

The regulatory expertise 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. With hundreds of orphan projects, our track record speaks for itself.

A pioneering technique that addresses the complex challenges of rare disease trials. By working with patient advocacy groups and key opinion leaders, we ensure that trial protocols are realistic given any limitations of the 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.

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

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Proud winner of Best Orphan Drug CRO ROAR Awards, for 2 consecutive years.
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Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, clinical trial delivery, and 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.