A Medical Device Daily
Contract research organization Cetero Research (Cary, North Carolina) reported what it called "enhanced focus" on conducting cardiac safety assessments through its CorWatch system, a suite of services designed for cardiac safety trials in any phase of development.
Cetero says CorWatch combines "significant clinical pharmacology expertise, strategic relationships with key core ECG laboratories, data management, study design consultation and program development."
Cetero is a provider of QTc data, QTc being the measurement of an electrical cycle in the heart that is dependent on heart rate. The company says it has conducted more than 20 trials and recruited more than 2,000 participants in the last two years, "more than any other CRO in the world." It reports having the largest bed capacity of any CRO and the most experience conducting QTc trials.
Alan Copa, president of PRACS Institute (Fargo, North Dakota), a founding company of Cetero, said, "QTc assessments are critical to drug development programs … The key is to be able to conduct a trial in one place, with the least number of groups."
The required identification of any QT/QTc interval prolongation and proarrhythmic potential for new non-antiarrhythmic drugs is based on the FDA's ICH E14 industry guidance. Cetero says that "a thorough, well-designed and effectively executed QTc trial with statistical significance lies at the heart of submitting an NDA.
"Cetero is focusing on cardiac safety assessments based on how crucial they are to our clients. We have formed strategic partnerships with core ECG laboratories and equipped our facilities with state-of-the-art equipment and experienced staff," said John Capicchioni, VP of business development.
Firm launches services for startups
Global Medical Group (GMG; Baltimore), reported that it has launched a suite of services for assisting startup life science companies for marketplace entry.
GMG said it can offer assistance with securing angel and venture capital funding, navigating the regulatory process, reimbursement strategy, management distribution, channel development, and business planning.
"We have encountered many medical device and pharmaceutical manufacturers with sound science and exceptional technology behind their products", said Laura Jordan, co-founder and CEO. But he added that these companies fail "because they do not have the resources to bring their products to market. GMG is set up to aid our clients in addressing barriers to market entry."
Jordan said that each GMG client undergoes a needs-based assessment to address the various components of their business plans from seed funding to networking international resources.
Jordan said. "Our team of experienced professionals partners with our clients in finding and managing business resources."
Just founded, GMG is a subsidiary of the JGS Group (Baltimore/Philadelphia/Denver, Colorado), a provider of reimbursement intelligence for medical technology companies.