Outsourcing Makes Inroads In Pharma IT Management
For pharmaceutical companies, outsourcing is an increasingly acceptable solution to burgeoning IT requirements and regulatory mandates.
HCL America, the U.S. branch of an Indian company that has offered traditional outsourcing services for 30 years, decided about four years ago to focus on nine industries, including life sciences.
“Companies began asking us if we could do clinical data management,” Pradep Nair, vice president for Global Life Sciences Practice, told PIR on March 21 at the Interphex conference. HCL America entered the clinical data management field and now assists companies with protocol generation and case report forms design (CRFs).
“One of our largest customers, Merck, has a homegrown data management system that is being maintained by HCL,” he said.
Court Square Data Group in Springfield, Mass., manages 1,500–2,000 servers for Pfizer, said Patrick Porter, president of PR firm Eikon. “Pfizer and the big companies went to outsourcing, but the small companies did not,” he noted.
This can pose “a big problem for the little guys,” said Court Square’s John Graham. “A small biopharma will have 100 guys and three doing IT. They can’t know what we do with 80 people [devoted exclusively to IT],” he said. Court Square CEO Keith Parent said the company’s approach in working with small-to-medium pharma firms is to tell them to adapt their current IT methods to the firm’s general framework.
On the regulatory side, HCL America offers electronic clinical technical document (eCTD) submission and automated compliance — including electronic data capture (EDC) — as part of the company’s clinical data management solution, Nair said. “Today, with most of [our clients], it starts typically with CRF report forms and trial management systems on paper, and we try to move them into automated procedures for everything — patient recruitment, investigators (the doctors) and site management.”
“There is some resistance [to EDC], but the FDA is pushing it,” Nair added. “Traceability is a problem if it’s not automated,” he said, explaining that his firm supports all the documentation for FDA submissions.
The company has also been filling customer demand for software design for Class II and III devices. “It’s predominantly device and data management. A lot of companies are looking at the Indian and Chinese markets as growth markets, so a lot of companies are looking to outsourcing to see what they can manufacture there,” Nair said. Most of HCL’s life sciences outsourced personnel are in New Delhi, Chennai and Bangalore.
Implementing Good Systems Practice
For its part, Court Square is emphasizing the IT Infrastructure Library (ITIL) good systems practice (GSP) as a way of helping pharma companies comply with Part 11. “The FDA is looking for demonstrated control, and ITIL GSP provides that. The documentation provided for Part 11 was useless,” said Graham.
The key is thorough implementation of GSP instead of a haphazard approach. “If compliance and managed services are a fire drill for your company all the time, you’re in trouble,” said Porter.
Parent said he has turned down jobs from pharma companies that aren’t interested in letting his firm provide them with a complete IT package. “Just monitoring is not enough. We’ll show you a better way to do it — that’s what GSP is all about,” he said. — Martin Gidron