| With a strong IT base and a booming clinical | | | | their global server, software and other |
| research industry India is proving to be a good | | | | infrastructure with addition of user licenses to |
| destination for Clinical Data Management (CDM) | | | | extend their data management business. Hence, |
| outsourcing. | | | | they can save costs on some hardware and |
| | | | | software to start the data management business. |
| The Clinical Data Management (CDM) industry is | | | | In the FTE model, pharma companies outsource |
| the fastest growing and possibly the most | | | | the job of developing the facility, offices and |
| profitable segment of the bio services industry. | | | | human resources (FTEs) to a service provider, |
| During 2006-07, it grew to $40 million, a growth | | | | who could be a CRO or an IT company with the |
| of 53 percent over the previous year. The | | | | understanding of the clinical trial data management |
| outsourcing of MNC clinical trials to India is a prime | | | | and biostatistics business. The human resources in |
| growth driver for this market, though they are a | | | | this case could be statistical programmers, |
| few large dedicated CDM companies of Indian | | | | statisticians, data viewers, DB designers and |
| origin as well. The Indian clinical trials market in | | | | medical writers. |
| 2006 was $140 million and has been growing at a | | | | In the functional service provider model, pharma |
| Compounded Annual Growth Rate (CAGR) of 40 | | | | companies provide the hardware, software and |
| percent for the last three years. At this rate, it is | | | | arrange for their installation and training. This |
| likely to scale up to $600 million by 2010. | | | | model is essentially an extension of the contract |
| Correspondingly, CDM market is expected to | | | | staffing model as the service-provider provides |
| ramp up to $150 million by the same time. | | | | both the office and manpower. The vendor will |
| | | | | act as a Functional Service Provider (FSP) on |
| Trends, evolution and the outsourcing boom | | | | project/protocol basis after certain pre-decided |
| Earlier, CDM was considered an integral part of | | | | years. |
| clinical development and was typically an activity | | | | |
| performed by in-house teams in global pharma | | | | Developments |
| companies. With the maturing of the IT and | | | | Some great advancement in CDM in India includes |
| Business Process Outsourcing (BPO) process | | | | quality of results in limited time as well as |
| management, and the volume of CDM work | | | | reduction in use of paper. Until now, India has |
| increasing, as well as with the introduction of | | | | witnessed different types of players venture into |
| customized software for CDM, a number of | | | | the CDM area. Some of them are full- fledged |
| companies started outsourcing this to Clinical | | | | CROs starting to hive off data management units |
| Research Organizations (CROs) and more recently | | | | into independent offshore CDM hubs, while some |
| to IT companies based in India. | | | | of them are IT/ITES companies that leverage |
| The spending of pharma companies in CDM runs | | | | mature software processes, technology |
| into millions of dollars. Typically, data management | | | | expertise, the ability to scale and domain |
| costs account for 20-35 percent of the total cost | | | | knowledge to provide data management solutions, |
| of a clinical trial. Similarly, according to various | | | | and yet others are pharma companies setting up |
| reports about CDM and biostatistics, there have | | | | captive biometrics and data management |
| been over $8-10 million deals per year from Big | | | | operations solely on their own or through |
| Pharma companies. Major work for CDM comes | | | | partnerships. |
| usually in phase III trails. For international trials, | | | | And as far as the Indian pharma industry is |
| phase II cost usually ranges from $200 to $350 | | | | concerned, it has made great strides in novel drug |
| million and CDM would get budgeted between five | | | | discovery in the past three to four years. In fact, |
| to 15 percent of this total. | | | | the industry is at a stage where it can finally |
| | | | | throw off the 'generics-only' tag that it has |
| Why India? | | | | traditionally carried. There is a concerted focus |
| CDM is highly technology-driven and needs the | | | | now on developing data management and |
| use of IT systems, hence pharma companies | | | | analytics capabilities that are required to support |
| outsource it to BPOs and IT companies and India, | | | | drug development. On the development front, the |
| with its huge clinical and medical talent, is | | | | industry has adopted leading products in the areas |
| increasingly being looked at as 'the' strategic | | | | of EDC, CDM, CTMS as well as Adverse Event |
| offshoring destination for services related to | | | | Reporting (AERS). |
| clinical research. This is borne out by the fact that | | | | Similarly, CROs, large and small, are creating |
| today almost 82 percent of US companies rank | | | | facilities and infrastructure, and spending millions of |
| India as their first choice for IT outsourcing | | | | dollars for procurement, installation and training for |
| destination. | | | | the highly publicized 21 CFR Part 11 compliant |
| Another contributing factor for outsourcing to | | | | software (like Clin Trial, Oracle Clinical and |
| India is that it gives clients a cost benefit of 65 | | | | PheedIt), to become 'Full/Complete Service |
| percent, so they are likely to outsource more to | | | | Provider'. Some CROs are getting ISO 27001 |
| India. Yet another reason would be drug | | | | certification, which ensures information security. |
| development process is highly uncertain and there | | | | The bigger global players are scaling up their |
| are cycles of peak and troughs. In this scenario, it | | | | operations to hire more people and moving their |
| makes sense for pharma/biotech companies to | | | | business from elsewhere to India and are catering |
| keep only a minimal staff on their rolls and use | | | | to the growing demand for cost effective and |
| outsourced help during periods of peak workload. | | | | good quality data management. Besides having |
| Besides following GCP and information security | | | | access to the best of CDM softwares and |
| policies, there are no major regulatory | | | | systems available globally, the talent base has also |
| requirements for CDM in India and this is an added | | | | matured. Global pharma companies have trained |
| advantage. The (US) Food and Drug | | | | many members of the staff of their India based |
| Administration (FDA) is accepting data from Indian | | | | vendors hence there is greater parity with global |
| clinical trials and data management. Secondly, the | | | | capabilities than a few years back. India does |
| MNCs are more than willing to outsource their | | | | more than 60 percent of all outsourced CDM |
| needs to India because of its technological | | | | work now; though Australia and to some extent |
| innovation, creditable quality, operational flexibility, | | | | China have started work in this area. |
| cost effectiveness, time-to-market and | | | | |
| competitive advantage. | | | | Going ahead |
| There are over 70 companies in India offering | | | | CDM market in India will expand rapidly in the |
| services in this niche area. Most of them find it a | | | | years to come as long as Indian companies |
| logical extension of their other bio-services | | | | areable to offer large scale data management |
| business. These include CROs, clinical trial | | | | services at very optimal costs. The concept of |
| organizations, IT services companies and hospitals. | | | | gaining advantages through outsourcing data |
| There is a mix of players who are involved in | | | | management work to India has now been proven |
| CDM. Besides, there are also medical transcription | | | | beyond doubt. Also, as major biopharma |
| players who are getting a major chunk of work. | | | | companies have outsourced their work to India |
| | | | | and have gained tremendous advantage in terms |
| Outsourcing Business Models | | | | of cost savings and speed, the next tier of |
| India is emerging as an IT superpower and a | | | | companies is now increasingly looking to outsource |
| clinical research hub. This has resulted in a | | | | and are exploring possibilities. This will boost the |
| higher-than-expected growth of clinical | | | | flow of work to India. |
| research-related services in India, including CDM. | | | | EDC is an emerging trend and a majority of the |
| The Indian IT industry is rapidly moving away | | | | trials in the coming years will shift to this mode of |
| from cost as its differentiator and is building | | | | data transfer from the traditional paper based |
| competencies to tackle client requirements much | | | | data capture. This will further facilitate outsourcing |
| higher up in the value chain. This, coupled with the | | | | of CDM. |
| high speed and quality of service, has catalyzed a | | | | So undoubtedly, CDM market in India is poised for |
| spurt in outsourcing in domain intensive areas like | | | | a steady growth. |
| CDM. Quality and fast response are the new | | | | While there will be competition for work between |
| buzzwords to dominate business processes which | | | | CROs and IT companies, most companies will |
| ensure accurate, reliable services to the | | | | choose IT companies for work of a more |
| customers and an efficient business model will | | | | transactional nature and prefer CROs for work |
| certainly help. | | | | requiring deep clinical research domain expertise. A |
| There are three main models—the individual | | | | few companies are already working on this model. |
| project outsourcing model, the Full Time | | | | What would matter most in the long run, in both |
| Equivalent (FTE) model and the functional service | | | | cases, are consistent, flawless execution |
| provider model. | | | | capabilities. |
| Big CROs offer their Indian counterparts to use | | | | |