On the heels of well-grounded success in Clinical Research Outsourcing (CRO), the ever-evolving pharmaceutical industry is exploring new ways to leverage outsourcing to address challenges of increasing cost pressures and shorter drug-development cycle times. Pharma companies are turning to Functional Service Providers (FSPs). FSPs provide services function by function but have the added advantage of providing full service through IT+BPO+IS. India’s service providers are on the leading edge of FSP services and are positioned for helping pharmaceutical companies transition to a single strategic partnership model for clinical trials. I spoke with VK Raman, Head of Domain BPO Services at TCS, about these trends.

The key strengths of FSPs lie in converting complex business processes into simpler activities with quality measurements; in turn, this helps the teams produce consistent, repeatable results every time. FSPs also bring in synergies with their IT background, which certainly brings about productivity improvements. In addition, FSPs use Six Sigma and Lean methodologies for process reengineering, which leads to significant cost savings. 

Q. What are the pros and cons of a pharma company establishing its own captive unit in India rather than outsourcing to a third party? 

VK Raman: Today, few pharma captive units carry out clinical development activities out of India. A captive unit requires lot of leadership commitment, involvement from headquarters, huge capital expenditure/overheads, and hiring local talent who gel with the values and culture of the global pharma company. Also, minimal external benchmarking exists with regard to operational metrics, key performance indicators, and continuous improvement.  

Q. How important in provider selection criteria are the provider’s global footprint and a multilingual workforce? 

VK Raman: A provider’s global footprint as well as a capability to have multilingual workforce forms a key component that influences the ante in the business decision. In recent years, clinical research activity saw a huge shift towards the emerging markets of Asia Pacific, Central and Eastern Europe, and Latin America. Pharmaceutical companies need to conduct medical affairs / post-marketing trials wherein the documents must be in local languages. Hence, a global footprint with a nearshore delivery center that has the capability to attract and retain local talent coupled with multilingual capabilities creates a huge benefit to pharmaceutical companies.

Q. Other than pharma domain knowledge, are there provider selection criteria a pharma company should use that differ from selecting a service provider for other types of BPO processes?

VK Raman: The FSP partner should be an ethical and high-integrity company. In addition, pharma work involves knowledge services; so the work atmosphere should encourage dialog, debate, and be conducive for developing knowledge. The social image of these companies is also important since activities are likely to be reviewed by regulatory authorities. Therefore, the partner should have a sound image and be perceived as a stable, long-term player in the market. 

Q. Too much focus on getting the lowest-cost services is known to be a major problem with value and quality outcomes in any outsourcing arrangement. How should pharma companies approach a full-service provider arrangement to ensure more strategic value beyond cost benefits from labor arbitrage?   

VK Raman: Ensuring strategic value from a partnership -between a pharma company and a full-services provider requires many key relationship elements. 

 First, there must be a robust joint governance structure with leadership members from strategic, operational, and business transformation teams. Other imperatives include: 

• Transparency in knowledge-sharing and best practices
• Baseline operational metrics and defined year-on-year productivity improvements with measurement systems, rewards, and recognitions
• Sharing of metrics and balanced scorecard to assess ongoing quality and health of the partnership
• Creating and leveraging cross-functional synergies within the partnership

Q. What about the multisourcing aspect? Are there challenges that occur from multisourcing, or synergies that could be achieved if a pharma company outsources data management to one outsourcer, medical writing, to another, regulatory reporting to another provider, etc.?   

VK Raman: As there are interdependencies between each function (data management and statistics, programming, statistics and medical writing, and regulatory reporting), it makes logical sense to have a single-sourcing model that will help create synergies, reduce processing time, enhance communication between functions and teams, optimize resources by cross-functional training, and align the teams according to therapeutic areas. 

Q. Clinical fraud is a major problem that affects costs as well as the integrity of clinical trial data. How can an outsourcing provider help in the effort to detect fraud at a clinical site? How does the full-service provider’s ability to detect fraud differ from a CRO’s ability?  

VK Raman: Clinical fraud is not an isolated phenomenon; it is rampant and takes a pathological course. It starts from incomplete, inaccurate information from the site or from delayed/missing information and lack of accurate communication from the site. 

It then navigates to discrepancies between different clinical databases requiring same information or missing updates. It ends with less transparency in processes, procedures, and dependencies. 

As an outsourcing provider, how do we tap into this and curb it? This necessitates having diagnostic tools for fraud (pathology) and anti-fraud tools. How do we execute it? First, by mapping processes and activities in detail, identifying inefficiencies, work on SLAs. Next, we conduct due diligence or multiple follow-ups with sites. We also “processize” the checking of site documents. For example, TCS currently provides financial disclosure services and identification of debarred investigators. We also use central hub information databases and check for timely updates. We automate wherever possible. Finally, we use tracking tools (Macros, Formulas) for constant health check of the project. 

Q. What competitive advantages can a pharma company achieve by outsourcing post-market services to a full-service provider? 

VK Raman: These days, post-marketing surveillance is a mandate. Most post-marketing services revolve around surveys and patient response to a drug in co-morbid, concomitant medications and s other such conditions. A full-service provider such as TCS will have such technologies as

• IVRS, IWRS
• ePRO- PDA, electronic diaries
• Help desk, treatment compliance check
• Survey analysis, automation as well as standardization

 Q. With an eye to the future after knowing the relationship is working well, how can a pharma company and its full-service provider enhance their ability to create value through the relationship? For example, are there strategies they should adopt to create value through a higher degree of collaboration or through risk-reward pricing?  

VK Raman: There are opportunities to move towards study-based project outsourcing over a period of time. Secondly, an FSP could host its own systems to carry out the data-management activities. Thirdly, the pharma company and FSP could move towards joint development of protocols and processes to speed up drug discovery and post-approval acceleration of marketing. The opportunities are only limited by imagination. 

V K Raman, Head – Domain Business Processing Services, TCS,  is responsible for TCS’s  business processing services for SG&A processes as well as processes that have an impact on COGS for industries such as Lifesciences, Manufacturing, Retail & Travel, among others. He has been instrumental in managing and growing TCS’s business services to the five Top 10 pharmaceutical companies that have “Experienced Certainty” with TCS. VK has over 20 years of experience working in different organizations and has expertise across finance, risk management and Six Sigma deployment.  He has held various positions with GE, Citibank, DEC and Tata.  V K Raman was the CEO of Global Realty Outsourcing, India operations, before he started his stint with Tata Consultancy Services. 

Since 1998, freelance writer Kathleen Goolsby has studied outsourcing relationships’ successes, failures, trends, and best practices. She has interviewed more than 860 executives at buyer and service provider companies and is the author of “Critical Requirements for Building and Sustaining a Successful Outsourcing Relationship,” a chapter in Global Outsourcing Strategies: An International Reference on Effective Outsourcing Relationships (December 2006, Gower Publishing). As a freelancer, she also currently serves as the Senior Writer for Outsourcing Center (whose parent company is sourcing advisory firm, Alsbridge) and has authored dozens of articles as well as white papers. In a past role, she was editor of Outsourcing Venture (a former print publication). You can contact Kathleen at ksgoolsby@gmail.com.

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