EResearchTechnology and nSpire Health, i3 Research and Clinsys Clinical Research – Clinical contract news

eResearchTechnology and nSpire Health have formed an alliance to provide integrated cardiac safety and pulmonary core laboratory services to clinical researchers on a global scale.

" This alliance addresses a growing need in clinical research to offer comprehensive services in these two closely related areas of clinical study ," said Michael McKelvey, president and CEO of eRT. eResearch's specialty lies in electrocardiographic (ECG) and other eclinical technologies, while nSpire is a provider of respiratory clinical trials services, including cardiopulmonary exercise testing, high definition pulmonary diagnostics systems, spirometry, and home monitoring.

Together the two firms said they will deliver a combined solution to meet the " increased demand for cardio-pulmonary safety and efficacy services " during clinical trials, in part caused by an increased interest in using inhaled therapeutics.

" While many sponsors recognise and source each company for its respective area of expertise, customers are increasingly seeking consolidation and streamlining in all phases of a clinical trial ," said McKelvey.

Services offered under the partnership will range from project planning and set-up through to study conduct, management, and data delivery for primary and secondary cardiac and respiratory clinical trial endpoints.

nSpire Health will provide the core lab data management software, quality assurance services, and various electronic diary respiratory diagnostic measuring instruments.

eRT will perform digital collection, measurement, interpretation, review, and distribution of cardiac safety data through its workflow-enabled data management system.

" This partnership leverages the cardio-respiratory specific technologies and data management services from each company into one unified source, reducing costs and accelerating time to market for emerging inhaled therapeutic trials ," said Michael Sims, president and CEO of nSpire.

Recently, US contract resesarch organisation (CRO) i3 Research has bought a Russian counterpart, Lege Artis .

i3 said that the purchase will give it new access to clinical sites and investigators in Russia, in addition to Belarus and Ukraine, where Lege Artis also has operations.

" Russia has become a strategic geographic area in the drug development process, with well educated and experienced medical doctors and a vast population of patients who are interested in participating in clinical trials ," said i3's CEO Glenn Bilawsky.

The Moscow-based CRO will be absorbed into into i3's operations although it will still continue to be headed up by its current founder and CEO, Dr Tatjana Zwereva.

In other clinical news, Clinsys Clinical Research has launched a new clinical resourcing division called Clinsys Alterna, which the firm said utilises its global project management solution (Clinsys GPS) to facilitate customised Phase I-IV clinical resource services.

" The new division demonstrates Clinsys commitment to aligning its service offerings with its sponsors and the life sciences industrys continuously evolving staffing needs ," said the company.

According to Clinsys, its new resourcing division provides " alternative solutions to the conventional outsourcing model. "

The custom-designed, time-sensitive clinical solution enables sponsors to engage its services in site management, clinical monitoring, project management, drug safety, regulatory and medical writing on a contract basis, said the CRO.

Company CEO David Williams added that the firm now provides a " targeted and flexible " clinical resourcing model that adapts to best serve a sponsors trial management needs and allows resourcing in an " innovative way that both maximises efficiencies and decreases deliverable timelines ."