The CRMG team has experience in working with special patient populations, including pediatrics and patients with rare diseases, and the key to our success in these areas is simple. It is our mix of highly experienced clinical operations and medical professionals, who have a passion for finding cures, no matter what the size or complexity of the program. Whether it is supporting a study for a rare/orphan disease, renal or hepatic safety studies, or working with a pediatric population, CRMG understands the challenges.
Patient identification and medical complexities are key challenges involved in conducting studies for treatments of rare diseases. CRMG works to address these challenges by leveraging relationships with the appropriate academic, research and advocacy groups. We involve these groups early in study planning so that a robust and well-conceived clinical protocol, as well as patient recruitment and retention plans, are in place before the study begins. Further, we have established relationships globally with a number of different advocacy groups and specialty providers who share the same passion, interest and experience in working on these challenging studies. This allows CRMG to provide a variety of patient-centric services, as well as achieve a global footprint that many times is required to meet the sponsor’s enrollment needs.
With regards to pediatric clinical studies, CRMG understands the regulatory environment, as well as the ethical and emotional sensitivities that present unique operational challenges with pediatric clinical research. Our team is led by our Executive Vice President and Chief Medical Officer Dr. Richard Paul, a Joslin Diabetes Center (Harvard Medical School) trained physician who spent the early part of his medical career treating pediatric patients with Type I diabetes. The team works with sponsors to ensure that the protocol design and overall study plan balances the objectives of the trial with the heightened patient safety and ethical concerns of conducting studies in pediatric subjects. With our experience in understanding the nuances of performing clinical trials in these populations, including specialized approaches to dosing, definition of populations, and US and EMA regulatory requirements, the CRMG team can help you meet the pediatric obligations that accompany your product’s approval.
With experience in wide array of disease areas, we have supported clinical trials in special populations in recent years in the following:
- Infectious disease
- Metabolic disease