Precision Medicine & Genetics

Inform your Precision Medicine study strategy

Expert guidance and deep intel to guide clinical studies that use genetics

WCG and InformedDNA have partnered to optimize the design of clinical trial protocols to ensure that genetic information is appropriately applied to study design. Together, we’re helping sponsors and CROs identify hard-to-find patient populations, reduce their exposure to risk, identify broader indication applications, and increase the overall value of the asset being studied.

Global network of 550 clinical trial optimization experts
Industry-leading team of 50 genetic specialists and counselors
The combined intel of the WCG Knowledge Base™ and InformedDNA genetic database
The challenges and opportunities for clinical trials in the era of Precision Medicine

With the rise in precision medicine, protocols have become increasing complex, presenting challenges to sponsors and CROs who are designing trials that include genetic components. At the same time, precision medicine trials also provide the opportunity to uncover greater value for treatments.

As industry-leading sponsors and CROs intensify their focus on rare diseases and greater personalization, recruiting patients can be more difficult. However, a sponsor or clinical research site with an understanding of the genetic complexity of disease can overcome this challenge by using genetic data and counseling to select a study population that is likely to benefit from the asset being tested.

To make this shift, sponsors and CROs need the right expertise and infrastructure to deploy genetic-oriented trial solutions.

The Center for Genetics and Precision Medicine in Clinical Trials

The Center for Genetics and Precision Medicine in Clinical Trials unites WCG’s global network of 550 experts in clinical trial optimization and its proprietary industry Knowledge Base™ with InformedDNA’s industry-leading team of 50 genetic specialists and counselors and its extensive genetic database across all therapeutic categories.

Together, the partnership delivers unparalleled insights and guidance regarding the optimal use of genetics in clinical research to Sponsors and CROs. The partnership specifically tackles the challenges and opportunities of applying genetic information to trial and protocol design and of harnessing the power of genetics to identify, recruit, and manage patients in clinical trials.

Guiding precision medicine trial strategy from startup to execution

Protocol Development

Our experts develop inclusion and exclusion criteria and provide other protocol design services that involve genetic components, such as planning and executing advisory board meetings with physicians to collect their feedback and increase their participation. We also assist sponsors and CROs with identifying sites and analyzing the geographic distribution of referring providers to increase the probability of trial success.

Patient Identification

We identify potentially eligible patients through outreach programs and InformedDNA’s internal patient database. Through our partnership with InformedDNA, we also offer individualized genetic counseling and screening appointments. Genetic counselors collect detailed medical and family histories during screening programs, which helps sponsors and CROs determine inclusion/exclusion criteria for their trials.

Patient Engagement

We aid patient support groups, foundations and organizations with patient support services by adding genetics experts to their care teams and by helping direct patients into genetic counseling and screening appointments. Our well-informed experts provide medical management guidance to patients and physicians, improving patient care and increasing provider satisfaction.

Data Collection & Utilization

We collect the appropriate patient experience data and use it to build the patient input and clinical development plan documents that regulators require. We also work with sponsors and CROs to collaboratively publish or present data they obtained either through a clinical genetic counseling program or through a review of literature and natural history studies that contain genotype/phenotype data.

Deep expertise in a broad variety of specialties:

Cancer Genetics

Cardiac Genetics

Neurogenetics

Ocular Genetics

Reproductive Genetics

Pharmacogenomics

Rare Disease Genetics

Featured Experts from the Center for Genetics and Precision Medicine in Clinical Trials

Rebecca Sutphen, MD, FACMG

Chief Medical Officer
InformedDNA

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Lindsay McNair, MD, MPH, MSB

Chief Medical Officer
WCG

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Jill Johnston

President, Site Activation
WCG

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Karmen Trzupek, MS, CGC

Director, Ocular and Rare Disease Genetics Services
InformedDNA

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Tricia See, ScM, CGC

Cardiac & Neurogenetics Team Lead
InformedDNA

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Suzanne Caruso

Vice President, Clinical Solutions
WCG

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“Forging new pathways to support clinical development in genetics and precision medicine is critical to help create a world where no life is limited by genetic disease. The efforts of WCG and InformedDNA to ensure access to genetic testing and counseling are an essential step to support the clinical development of genetic medicines and could benefit millions of patients suffering from rare and genetic diseases.”

Ron Philip, Head of Global Commercial at Spark Therapeutics, a fully-integrated, commercial gene therapy company that worked with InformedDNA as Spark prepared for the first FDA approval for a gene therapy for a genetic disease.

Precision Medicine & Genetics Resources

Consult with the precision medicine clinical study experts from WCG and InformedDNA

Complete this form to request a consultation with WCG and InformedDNA to assess your need, and discuss how our joint Center for Precision Medicine and Genetics In Clinical Trials can assist.