hase Forward, the US-based supplier of data management solutions for clinical trials and drug safety, has announced a “multi-year, multi-million dollar” agreement extending a previous contract with Everest Clinical Research Services.

With offices in Toronto, Canada and Little Falls, US, Everest is a contract research organisation (CRO) spun off from Pharmacia in January 2004 following the latter’s acquisition by Pfizer. Its portfolio of services includes clinical data management, biostatistics, trial subject randomisation, medical writing, support for regulatory submissions, and trial management and site monitoring through partners.

Under its agreement with Phase Forward, Everest is leveraging the former’s InForm Integrated Trial Management and its hosted Central Designer electronic data capture (EDC) solutions. “EDC technology is a key enabler of our core clinical data management service,” commented Irene Zhang, president and chief executive officer of Everest Clinical Research Services.

The Central Designer and InForm software have proved “an effective solution for providing our clients with the core components of this service: high-quality and timely data collection, cleaning and database lock”, Zhang added. “By adopting this technology in-house, we expect to bring even greater efficiencies to the management of clinical trial data for our trial sponsors.”

First-quarter gains

As of the end of 2008, Phase Forward had more than 90 CRO customers across its range of data management solutions. In the first quarter of 2009, the company’s CRO-related revenues grew by 52% year on year.

Phase Forward recently announced overall first-quarter revenues of US$48.8 million, up by 28.5% over the same period of 2008. Licensing revenues were 11.9% higher at US$14.1 million while service revenues climbed 36.6% to US$34.7 million.

InForm licensing, application hosting and related revenues came to US$36.4 million, 26.2% more than in Q1 2008 and accounting for 74.6% of total revenues in the latest quarter. Operating income rose by 16.6% to US$5.2 million and diluted earnings per share were US$0.09, the same as in the first quarter of 2008.

On a Generally Accepted Accounting Principles (GAAP basis, Phase Forward is forecasting EPS of between US$0.26 and US$0.29 for the whole of 2009, including expected dilution of US$0.04 to US$0.05 per share related to the recent US$14 million acquisition of Waban Software, a US-based supplier of platform solutions for automation and compliance in clinical data analysis and reporting, and to other accounting factors.

On a non-GAAP basis, Phase Forward has raised its full-year guidance from US$200-205 million to US$207-212 million, including an expected contribution of US$2-3 million from Waban. The non-GAAP EPS forecast for 2009 is US$0.51 to US$0.54, taking into consideration expected dilution of US$0.01 to US$0.02 per share from the Waban deal.