Clinical Trial Data Management Outsourcing India; A Review of Cost and Competition

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1 Clinical Trial Data Management Outsourcing India; A Review of Cost and Competition Dr Umakanta Sahoo, General Manager, Chiltern International Private Limited, Mumbai, India Key Words IT Information Technology FTE Full Time Equivalent ITES IT Enabled Services FSP Functional Service Provider CFR Code of Federal Regulations CRF Case Record Form Summary India has developed into a super power for IT skills and has become a major hub for pharmaceutical and biotech manufacturing And contract research, the outsourcing business in various other segments is also exhibiting promise. Clinical trial data management and statistical analysis is one such area which is growing rapidly, accompanied by a variety of players entering into different models of this business. The author reflects on the data management business in India and reviews the emerging outsourcing models in this growing industry. He has also attempted to work out a break-even analysis considering the projected investment on high quality and costly infrastructure like; hardware, software and human resources to augment the business and regulatory requirements of the industry. Learning from IT Outsourcing India is considered as a highly promising outsourcing IT and clinical data management destination because of its rich talent pool, technological innovation, creditable quality, operational flexibility, cost effectiveness, time-to-market and competitive advantage. Today, 82% of the US companies rank India as their first choice for IT outsourcing destination. India s wisdom and brainpower have attracted IT super powers, Bill Gates and Jack Welch to strike strategic alliances with Indian companies and opened world class technology centre in Bangalore, India. You may call it the business diversification from software development and IT solutions or leveraging the economies of scale; to do cost effective data entry and analysis or the horizontal ramification of clinical trial management, from clinical operations to data management, statistical analysis and medical writing, India is today one of the most vibrant locations in the globe. As the industry grows with forward and backward integration of different businesses, many players are modulating their business portfolio to accommodate the industry s needs. India has of late seen those changes in the operations of IT and ITES companies who have expanded their operations to other business segments like bioinformatics, life science, data management, etc. While some of them have already started working for pharmaceutical companies for their data management and biometrics outsourcing need, the rest are exploring to join them in the race. Similarly, the contract research organisations, large and small, are creating facilities and infrastructure, and spending millions of dollars for procurement, installation and training for the highly publicised 21 CFR Part 11 compliant software, to become a Full / Complete Service Provider. The bigger players are scaling up their operations to hire more and more people and moving their business from elsewhere to India and are catering to the growing demand for the cost effective and good quality data management.

2 Business Need Unlike clinical operations which invest in people and training, a typical data management unit needs to spend a lot in hardware, software, leased line connectivity and skilled people. The sponsors looking at the data management business through outsourcing from India expects the following from the service provider. A detailed data management plan Preparation of database in a desired software Comprehensive electronic validation and consistency checks Data entry including double data entry Query generation, handling, editing and tracking Database lock 100% Quality Control of the efficacy parameters and safety data 21 CFR Part 11 compliant Each Sponsor looks at 21 CFR Part 11 compliant software to be used for their data management. To ensure compliance to 21 CFR Part 11, you should have proper clinical data management systems with validated hardware and servers with proper performance, installation and operational qualification documentations with User acceptance test (UAT). This further necessitates the documentation of the training to the data management staff on servers, software, etc by a qualified team of professionals. Schools of Thoughts There are two schools of thoughts regarding the data management and statistical business in India. The first school of thought proclaims that unless you have well established software like Oracle Clinical or Clintrial, the data management system can not be 21 CFR Part 11 compliant. And since many global CROs and pharmaceutical companies have already used to this system and software, unless, you use the comparable system, you will not be able to compete with them. Hence, in their opinion, it is absolutely a must to invest in Oracle Clinical or some such validated software in order to obtain global data management business. But, considering the huge cost of this software, many ponder over the prospects of business to arrive at a conclusion whether to invest on data management or not. The second school of thought believes that the data management system can be compliant with 21 CFR Part 11 even without those validated software. They believe that a data management package well developed using Oracle 9i for database management (back-end operations) and Visual Basic or VB.net or JAVA or VC++ or some such software for front end for programming and interphase design, will give the desired output. They utilise the skill-sets of Indian IT talents and develop create a tailor-made clinical trial package for data entry and analysis. They ensure complete documentation of database preparation, installation of the software, trail runs, training, security checks, etc. to confirm compliance. Besides, there are many pharmaceutical sponsors who need low cost data management and statistical analysis and advocate the service providers to deliver using MS Access, Excel, etc. for small data set or non-regulatory projects. An Overview of Cost: The Breakeven Analysis Regardless of the school of thought you belong to, there is no way to avoid the heavy investment needed to set up a data management unit. It is believed that the cost of validating a particular type of software to meet the international and regulatory compliance is more or less equal to purchase a validated and proven software. The author, based on his experience, has attempted to work out the cost of setting up a data management unit in India and derived the breakeven point for the said business. On the basis of the breakeven analysis on Table 1 below, the author felt that in order to breakeven in a clinical trial data management unit in a year, the service provider should at least be

3 able to get 13 international projects of 100 patients each agreeing to reimburse US$ 5 per page of CRF and each CRF covering 100 pages of entered data. Table 1: Break Even Analysis Data Management Set up cost Year 1 Cost of manpower & set up for a team of 20 staff US$ operations Staff cost (Annual) 150,000 Office cost 125,000 Other overheads 50,000 Cost of staff and office maintenance 325,000 Data management Software 100,000 Thesaurus Management System 20,000 Application Server 12,500 Media Charges 625 Dictionary 7,500 Statistical Software 15,000 Servers 37,500 Operating System (Windows Server) 6,875 Implementation & Training Expenses 37,500 Personal computers (20 staff operations) 25,000 Leased line / T1 connection 2 MBPS (1:1) 50,000 Cost of Hardware, software 312,500 Total cost 637,500 Cost per page of CRF 5 No of pages 127,500 Breakeven Year 1 : No of trials 13 Year 2 : No of trials 20 Year 3 : No of trials 28 While US$ 5 per page would hopefully be acceptable in comparison to the global rate of US$ per page to most of the Sponsors, still there would always be an expectation of getting lower and lower rates to leverage the low cost advantage. Hence, the charge out rate per page may not increase over years because of increased competitions. The cost of licence of software may increase depending on the regulations and number of users. On the contrary, the staff cost and other overheads may increase by at least 20%. In that situation, the unit to breakeven should attract at least 20 studies in 1 st 2 years or 28 studies in the 1 st 3 years. Emerging Outsourcing Models Indian industry has witnessed a growth in the amount of clinical trial data over last decade. The success of the IT industry in India has instilled confidence amongst CROs and the pharmaceutical companies to venture into various models of data management outsourcing. Few CROs have created data management infrastructure to provide a basket of services as a Preferred Full Service Provider including clinical trial management and data management. The big CROs offer their Indian counterpart to use their global server, software and other infrastructure with addition of user licenses to extend their data management business. Hence, they have the cost saving on few hardware and software to start the data management business. These CROs also offer stand alone data management services.

4 Global/ Local CROs / Pharma Companies Preferred Full Service Provider Model Trial Mgt & Data Mgt Services Global CROs / IT Companies with capability & infrastructure Functional Service Provider Model Project Based Data Mgt Outsourcing Local CROs / IT / ITES Companies venturing DM business Players Retained Full Time Equivalent Model Outsourcing Models Contract Facility & Staffing for Data Mgt Services Another model that is becoming popular for a few selected Pharma companies in India is the retained Full Time Equivalent (FTE) Model. In this model, the pharma companies outsource the job of developing the facility, offices and human resources (FTEs) [Statistical Programmer, Statistician, Data Viewer, DB Designer and Medical Writer] to a service provider, who could be a CRO or an IT company with the understanding of the clinical trial data management and biostatistics business. The pharma companies provide hardware, software and arrange for their installation and training. This model is essentially an extension to the contract staffing model as the service provider provides the office and manpower both. This model promises the vendor to act as a Functional Service Provider (FSP) on project/protocol basis after certain pre-decided years. This model demands a lot of initial investment and provides an opportunity for the local service provider to learn tricks of the data management business besides promising a lot of future core business as an outsourcing partner. Main competitors in this kind of business models are the local CROs and the IT / ITES companies who plan to diversify into data management segment. Competition As of today, India has witnessed different types of players venturing into the clinical trial data management business, some of them are full fledged CROs starting separate data management units, some of them are IT / ITES companies diversifying to data management business and some are pharmaceutical companies setting up biometrics and data management operations solely on their own or through partnership, and some are entrepreneurs not related Pharma or CRO or IT business, but joining the fray looking at the prospects of the business. CROs Quintiles in Bangalore is expanding the data management team by moving work to India and has hired 187 people in data management. SIRO Clinpharm has a full fledged data management unit and is also working with Pfizer on a retained FTE model providing contract staffing operations. ICON Clinical Research has acquired a Chennai-based data management company, Biomines Research Solutions which will focus on data management and biometrics services. Pharmanet s (now SFBC International) Bangalore has an operational data management and biostatistics unit which is handling a lot of clinical data management work in coordination with their UK and European office. Asian Clinical Trial, ClinInvent, DnO, all Mumbai based clinical CROs, have invested on oracle clinical software to provide data management services to global Pharma companies. Acunova, an offshoot of Manipal group of hospitals has expertise in bioinformatics and medical software and offers clinical data management and biostatistics services to Pharma companies, besides the site management and contract research capabilities. Synchron, a local CRO offers complete clinical data management services for data processing, analysis and management from their Bangalore facilities. Besides, this many clinical trial CROs including Covance, Parexel, Chiltern, PRA International, MDS, Lambda, etc. are exploring the possibility of setting up clinical trial data management and biostatistics in India.

5 Some CROs are hiring resources in areas like biostatistics, SAS programming and other IT enabled services to work from Indian remote locations to support their active data management units. IT Pharma Ventures The author also highlights the involvement of IT / ITES companies like Accenture, Wipro, Intel, Satyam, Cognizant, IBM, Oracle and TCS in their bio-it initiatives in India. While some of them have actively started the clinical data management initiatives, others are planning to venture in IT solutions, installation and implementation, training and familiarisation supports. For example, Pfizer, India has signed a preferred provider contract for its Biometrics Division with Cognizant Technologies, India seeking data capture, data management, statistics services for its Phase I, II, III global trials. Similarly, Accenture is working exclusively for Wyeth in clinical trial data management with approx. 400 people working, having 2 offices and plans to open 3rd one. GSK's biomedical data sciences India and clinical data management center at Bangalore supports 36 studies for GSK worldwide with its 64 people on roll (can accommodate 120). Other IT / ITES Companies Bio-Initiatives IBM Life Science solutions aims to provide the IT infrastructure that researchers in biotechnology, pharmaceutical research, genomics, proteomics, and healthcare need to turn data into scientific discovery and new treatments for disease. IBM is also offering installation, validation and training support for clinical data management unit in India. Advanced Technology Center (ATC) of Tata Consultancy Services (TCS) in Hyderabad, in collaboration with the Council for Scientific and Industrial Research (CSIR) and supported by the Department of Biotechnology (DBT) aims to offer end-to-end solutions, services and products to life sciences and healthcare institutions worldwide. Another IT giant, Infosys has a life science division and they do claim to be involved global contract research. Besides, Infosys is partnering with Oracle India to provide installation, validation and training for Oracle clinical software. Satyam Computers in collaborations with Center for Cellular and Molecular Biology (CCMB, Hyderabad) develops software tools for genetic testing and provides manpower services, pharma-cum-database value added services to Pharma and biotech companies. Wipro Healthcare's Life Science division claims to offer pharma companies IT solutions that will reduce drug discovery and approval time. Sakti Group, a new york and bangalore based company is also doing data management and statistics work. Besides, this every small and big software companies are developing a package / software for clinical trial management, project management, documentation management, approaching small CROs, pharma companies, etc. Conclusion With India emerging as IT superpower and clinical trial hub, outsourcing to India for clinical data management is more obvious than predicted. Indian industry, which previously was relied on its cost effectiveness to attract customers, is now moving towards an entirely different direction. Quality and fast response are the new buzzword to dominate the business processes which ensure accurate, reliable services to the customers. While several models of businesses are emerging, only results will tell how many of them are attaining fast break-even after meeting global stringent regulatory standards. The time will test the success of experimentations of each of these players, who cross the critical path with proactive risk management approach in this world of innovations and new technology. The players meeting the industry expectations of increased adoption of global standards, regulatory compliances and the pressures of cost and cycle time reductions in drug development, with an efficient and effective data management system will survive. References Kush, R., et.al., eclinical Trials, Planning & Implementation, Thomson CenterWatch, 2003, p. 36.

6 Challenge and Opportunity on the Critical Path to New Medical Products, U.S. Department of Health and Human Services, Food and Drug Administration, March 2004, FDA Endorses CDISC Standards Development at Interchange, August 20, 2003, Web site accessed February Narayan Kulkarni, Data Manager, bioinfo.ernet.in/datamanager.pdf, February Pharmaceutical Research and Development in India Looking Up?, Dr Shoibal Mukherjee, Senior Director, Medical, Pfizer Limited, Author: Umakanta Sahoo, MBA, Ph.D. is the General Manager for Chiltern International Pvt. Ltd, India. Dr Sahoo has more than 12 years of experience in Indian pharmaceutical and CRO Industry and worked for global and local CROs in managing studies in different therapeutic areas. He can be contacted at Chiltern International Private Limited, Navkar Chambers, B Wing, 4th Floor, Marol, Andheri Kurla Road, Andheri (E), Mumbai : , Tel: / Fax: , website:

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