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High Point Clinical Trials Center Announces the Launch of Renal Impairment Clinical Study OfferingHigh Point Clinical Trials Center (HPCTC) has successfully launched its latest clinical study offering in Renal Impairment. The increasing demand from the pharmaceutical industry to understand the pharmacokinetic impact of novel drugs in renally compromised patients has prompted HPCTC to expand its clinical service offering. HPCTC is ideally suited to qualify and enroll Patients with renal insufficiency for these mandatory NDA enabling studies by leveraging a vast database of patients, a well-versed recruitment and screening staff, and a highly-efficient clinical operations team. "HPCTC is excited to offer another in-demand service to our biopharmaceutical and Contract Research Organizations (CRO) clients, further accelerating their drug development strategies," said Lorraine M. Rusch, PhD, President. "The evaluation of pharmacokinetic exposure in patients with renal insufficiency is a component of the New Drug Approval (NDA) package of trials for most Investigational Products (IP) intended for chronic administration. HPCTC is well positioned to execute these critical studies by providing scientific guidance, IP-parameter driven study design and an ideal operational structure." HPCTC ha also engaged with community-based nephrologists that contribute medical oversight and management of patients across the spectrum of compromise up to and including severe renal impairment. Dr. Rusch adds, "Renally cleared investigational products in clinical development require very particular dosing considerations when administered to patients with reduced kidney function. Our Physicians monitor and manage renally-impaired Patients carefully to ensure safety and appropriate trial endpoint objectives by interacting at the earliest stages of protocol design with our CRO and biopharmaceutical clients." HPCTC has an ideal operational structure for quick start up, recruitment and conduct. "Successful conduct of renal insufficiency studies is inherently dependent upon enrolling a notoriously difficult to recruit population," said Clayton Dehn, M.S., Vice President of Clinical Pharmacology Services. HPCTC's full-time recruitment agents are GCP trained and have extensive experience engaging Patient populations. Clayton adds, "Recruitment strategies for this population include pre-screening, the utilization of targeted and data-driven outreach, leveraging relationships with local nephrologists to augment recruitment, and our newest initiative, a mobile recruitment unit which allows us to expand our outreach. We also utilize our extensive Healthy Normal Volunteer database to find ideally matched volunteers." For more information, visit highpointctc.com. About High Point Clinical Trials Center (HPCTC) HPCTC was "born from biotech" in 2008 as an internal clinical research unit for TransTech Pharma, a drug discovery and development company, now operating as vTv Therapeutics. As the largest commercial clinical research unit in North Carolina, HPCTC conducts First-in-Human, clinical Proof-of-Concept, and traditional IND/NDA-enabling clinical pharmacology phase I/II trials for Contract Research Organizations, biotechnology and pharmaceutical companies worldwide. In addition to early development studies, HPCTC conducts studies across a range of therapeutic areas including metabolic disorders, pulmonary disease and CNS in a pleasant and comfortable environment managed by caring and experienced staff. Participant safety, protocol adherence, regulatory compliance and effective communication are the Company's top priorities. View source version on businesswire.com: http://www.businesswire.com/news/home/20180118006202/en/ |
