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 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.
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.
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.
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.
Rare Disease Genetics
“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.
Complete this form to request a consultation with WCG and InformedDNA to assess your need, or to schedule a complementary training session on Genetics in Clinical Trials with experts from our Center for Precision Medicine and Genetics In Clinical Trials for your team.