Clinical trial data management outsourcing to India

As the industry grows 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, says Dr Umakanta Sahoo in the first part of the article

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 per cent 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 (CROs), 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.

Business need Unlike clinical operations which invest in people and training, a typical data management unit needs to spend a lot on 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 per cent 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, by a qualified team of professionals.

Table 1: Break Even Analysis

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 cannot be 21 CFR Part 11 compliant. Since many global Contract Research Organisations (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 a must to invest in 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 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 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.

While US $5 per page would hopefully be acceptable in comparison to the global rate of US $10-12 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 per cent. In that situation, the unit to breakeven should attract at least 20 studies in first two years or 28 studies in the first three years.

The writer is General Manager, Chiltern International Private Limited, Mumbai