IT in Pharma
‘We are targeting large, established and growing pharma companies’
There is increased pressure on pharmaceutical companies from regulatory agencies to adhere to stringent deadlines in reporting adverse events (AEs). With the help of IT companies like Patni that offer Adverse Drug Event Reporting (ADER) softwares, the task becomes easier. Sanjiv Kapur, Senior Vice President and Head, Patni BPO discusses more details in conversation with Suja Nair
What role does Patni play in order to ensure drug safety and pharmacovigilance? At what stage of the clinical trial process is the ADER software implemented?
A service provider like Patni can help pharma and life sciences companies to focus on drug discovery and development, while leaving the AE processing to us. With an integrated business process outsourcing (BPO) and information technology outsourcing (ITO) solution leveraging a global delivery model, we help clients to reduce the cost of processing AE reports, improve the efficiency of pharmacovigilance operations, ensure timely reporting of AEs as per applicable laws and regulations and streamline their product delivery.
Pharma and drug manufacturing companies are facing increased pressure from regulatory agencies to adhere to stringent timelines in reporting AEs that may occur due to drug usage. Delay in reporting these AEs by the company, may result in heavy penalties, billions of dollars in terms of lost revenue, increased legal liabilities and even withdrawal of the drug from the market. Moreover, pharma companies and drug manufacturers need to report fatal drug reactions, severe and unexpected drug reactions as well as non severe drug reactions to regulatory agencies like United States Food and Drug Administration (US FDA) within a time period specified by the regulatory agency. These side-effects are referred to as AEs. The AE reporting software is implemented at the stage of the clinical trial itself.
In this regard Patni has partnered with Aris Global—provider of software solutions for life sciences industry to offer our clients a Software as a Service (SaaS) model that precludes the need to procure hardware and software licenses.
What are your offerings for pharma and biotech industries? How does one ensure that implementation of this software will speed up their efforts to meet guidelines on pharmacovigilance?
Patni provides integrated BPO and ITO solution for pharma and biotech industries. In pharmacovigilance we have ADEPT, Adverse Event Processing, in which we provide end-to-end service including capture, management, reporting and analysis of AEs from medicinal products, biologics, vaccines and medical devices. Then we have processing and reporting of clinical serious adverse events (SAEs)—it provide services for the capture, processing and reporting of SAEs from clinical trials. We prepare periodic reports like Periodic Safety Update Reports (PSURs), PADERs and annual safety reports. We also deal with operations intelligence-PV—in which our proprietary methodology assesses compliance of key drug safety components against applicable laws, regulations, guidance and industry best practices. It focuses on eight major domains and produces a quantitative risk profile across all domains. We also have a signal intelligence-PV—which provides formal validated signaling methodology that offers an efficient and scientific approach towards understanding a product’s risk-benefit profile. We follow FDA’s Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment guidance.
Our solution offers the choice of three well-known statistical methods—Multi-item Gamma Poisson Shrinker (MGPS), Bayesian Confidence Propagation Neural Network (BCPNN), and Proportional Reporting Ratio (PRR). Then there is workflow intelligence-PV—that mitigates operational risk enabling companies to optimise AE case processing through the application of modeling and simulation to map resources, timing, and costs. In risk management planning, we work closely with our clinical and safety departments to create the safety specification, pharmacovigilance plan, and risk minimisation plan. We also have application management that provides tier one help desk support, and client configuration change management etc. And last but not the least Patni also undertakes implementation/on-boarding services—dealing with project and change management, design, build, test (client configuration), validation (UAT), document standard operating procedures (SOPs), end user training etc.
How is the software installed and implemented? We have a joint access to the system with the client, which is configured to the client’s products and reports requirements. Our team collects, assesses, and enters all AEs and SAEs, governed by our SOPs and client-specific work-instructions. Clients can access the system at any time to view the status of cases and approve for electronic submission.
Has there been any instances of SAEs reported by clients? How is the same tackled by pharma companies/CROs? Do you have to comply with any regulatory guidelines?
Yes, there have been some instances of SAEs that we came across while servicing our customers. The procedures followed were as per the guidelines specified by US FDA/respective country regulatory agencies.
We have a validated 21CFR Part 11 compliant pharmacovigilance software. We have to comply with US FDA/country requirements related with data privacy, data security and data management. We are also subject to audit by US FDA.
How have you customised your offerings to meet the client’s needs?
Leveraging deep expertise, our team has developed advanced processes for implementation, on boarding and processing of AEs for various customers. We can work as per the clients processes or modify our processes as per the client needs. Our team creates a separate instance for each product of client and any AE related to that product is managed on that instance.
How do you plan to take this product forward?
We see huge potential in this segment. Stringent regulatory requirements combined with high cost of drug development and low success rate is prompting pharma companies to look for ways for cost reduction and productivity improvement.
We are targeting large pharma companies, established and growing companies, as well as emerging companies in North America, Europe and Asia Pacific. In Asia-Pacific (APAC), Japan and China are significant markets. This segment is highly driven by domain expertise and a blended onsite and offshore model. We are currently servicing clients based out of North America and APAC including Fortune 500 companies.
While big pharma companies would have their own platform, for tier II and tier III companies, our hosted platform is a significant value-add, as it eliminates the need for initial capital expenditure. In 2007, Patni acquired New Jersey based Taratec Development Corporation, a life sciences consulting firm for $27 million. Through this acquisition, we acquired a board of domain experts of repute, over 20 years of consulting expertise as well as specific product IP in pharmacovigilance and process simulations.