The ‘IT’ factor
Importance of information technology (IT) has no bounds in today’s technology savvy world. But how far has IT permeated the Indian pharmaceutical sector? Suja Nair explores
IT implementation has penetrated almost every business sector, with tools for strategy formulation and operational convenience. This has resulted in enhanced efficiency, stemming from its offer of increased flexibility and options based on certainties. Even though the pharmaceutical industry is a large, high-growth, globalised, and innovation intensive industry with the end product, medicines, meaning the difference between life and death, the industry has been a relatively late implementor of IT systems but results are already showing. Speaking about the benefits of IT implementation in this sector, Ghanshyam Naik, Vice President—IT, Wanbury, says, “We can not give direct estimates regarding revenue saved as all IT benefits are intangible, but it has resulted in saving time for business users in terms of data and analysis and though we are growing rapidly, the same set of people can exercise the control over the business or same people are able to generate the required MIS for the company. But in case of saving in time, we have faster access over the data now which helps us to take right decisions.”
Till recently the pharma industry was one of the few remaining major industries that developed new products primarily through a build-and-test method. There was always a need for a new product development toolkit containing powerful new scientific and technical methods such as animal or computer based predictive models, biomarkers for safety and effectiveness and new clinical evaluation techniques etc to meet the growing demands of this ever growing industry.
V T Gopinath, Executive Vice President, Actis Biologics adds, “We, at Actis, decided to implement IT solutions right at the inception stage, realising its potential. Being a research and development company in biotech sector, both the research data inputs and outputs are of utmost significance and the mammoth data analysis/storage would be practically impossible without IT solutions.”
The change is here
|“In any initiative, what is more important is inclusiveness of the users to derive maximum benefits and speedy solutions”
– V T Gopinath Executive Vice President
“We normally spend 1.5 percent of total turnover on IT in terms of new technology, new hardware and network component and new software.”
– Ghanshyam Naik Vice President-IT
|“Oracle’s comprehensive suite of applications for clinical development provides an integrated system for managing large volumes of patient data”
– Callum Bir Senior Director- Asia Pacific and Japan
Oracle Health Sciences Global Business Unit
Today IT plays a crucial role in the drug discovery and development process by providing predictability and efficiency along the critical path from laboratory concept to commercial product. For instance, a timely prediction of any impending failure of a project can save millions of dollars during research and development (R&D).
Affirming the same, Apurva Shah, Co-Group Managing Director and Co-Founder, Veeda Clinical Research, informs, “The importance Veeda puts on IT implementation is very high, we have sidelined about Rs 3 crore for IT this year. Teams are well trained to and above industry standards along with attaining and maintaining industry recommended practices and standards for IT implementation such as ISO 20000, GAMP and ITIL.”
Along the same lines Gopinath articulates that necessary investment has been made to develop and implement data management of research, clinical trials, access control system, accounting practices and payroll management. “This has helped us not only to optimise resources, but motivate the employees significantly. Though no specific outlay has been earmarked for investment, the management at Actis is committed to upgrade and expand further as and when the need is felt,” he adds.
Sea of opportunities
As the Indian pharma market is transforming itself to sustain its global image and reach, IT companies with end-to-end solutions capabilities that span hardware, software, integration and consultancy have realised the opportunities posed by this largely untapped segment.
Software and services provider Take Solutions is one such company that provides software solutions to the ever increasing demands of the life science sector. Some of their clients include Dabur, Intas, Merck, Johnson & Johnson, Amgen, sanofi-aventis etc to name a few. Ram Yeleswarapu, President and CEO, TAKE Solutions, informs that more clinical trials are becoming global in nature because government agencies like the US Food and Drug Administration (FDA) demand that pharma and biotech companies conduct more wide spread trials so that the drugs can be used by larger segregated and diverse patient populations. Thus the number of trial sites for pharma and biotech are increasing. He adds, “In order to collect all this data effectively we need lot of IT, here is where our role comes into play. TAKE is heavily involved in the drug development stage, dealing with clinical trials where we are involved with phase I to phase IV of human trials. TAKE’s core competency lies in data analysis, interpretation ie. statistical analysis or bio statistics and regulatory submission.”
Oracle Health Sciences with its worldwide presence, delivers a powerful combination of technology and comprehensive, pre-integrated business applications, including key functionality built specifically for pharma, biotech and medical device enterprises. Speaking about their products for Contract Research Organisations (CROs) Callum Bir, Senior Director, Asia Pacific and Japan, Oracle Health Sciences Global Business Unit informs that CROs increasingly require software applications that will help them automate and effectively manage the clinical phase from study setup through submission. “Oracle’s comprehensive suite of applications for clinical development provides an integrated system for managing large volumes of patient data, as well as sophisticated tracking, analysis and reporting capabilities. Today, hundreds of life sciences organisations are harnessing the power of Oracle’s clinical solutions to accelerate insights for better health. In India, this allows CROs to leverage standard-based, trusted, proven systems to provide unparallel quality clinical services as well as differentiate themselves in the highly competitive outsourcing market,” explains Bir.
|“Teams are well trained to and above industry standards along with attaining and maintaining industry recommended practices and standards for IT implementation such as ISO 20000, GAMP and ITIL”
– Apurva Shah Co-Group Managing Director and Co-Founder
Veeda Clinical Research
|“The scope of IT in life sciences industry is immense, it starts from the point of drug discovery, drug development, launch of the drug, commercialisation etc; all this shows that the role of IT is unquestionably extremely high.”
– Ram Yeleswarapu President and CEO
|“Extensive vendor and in-house training has been provided to Veeda staff for all software.”
– Binoy Gardi
The industry is going through many important structural changes, mainly driven by technological and institutional needs that have affected all stages of its value chain. In turn, this has led to changes in the way companies work and plan their global strategies. Meeting IT requirements also plays a key role in positioning any company in the global market since competition has narrowed the chances of survival for only the best in the industry.
Major pharma companies are increasingly looking towards mergers and acquisitions (M&As) with a revenue perspective, as acquiring companies can help close gaps in their profile, for example, Piramal Healthcare’s acquisition of Minrad International and Sun Pharmaceutical’s long term bid to take over Taro. IT plays a very crucial role in the long term aim to spread out in different geographies and generate more revenues through M&As and research alliances with global partners. Yeleswarapu says, “The scope of IT in life sciences industry is immense, it starts from the point of drug discovery, drug development, launch of the drug, commercialisation etc. All this shows that the role of IT is unquestionably extremely high. Several automated software systems are required to really take the entire gamut of services from the discovery phase to the next phases.”
Recently Veeda implemented Clintrial, a leading Clinical Data Management (CDM) tool to strengthen its data management backbone. Clintrial will provide Veeda easy integration with other systems in the clinical trial space resulting in secure and faster access to time-sensitive data. Clintrial was jointly implemented at Veeda by Phase Forward and IBM India. The process included IBM configuring a pilot clinical study chosen by Veeda as well as providing support to the Veeda team and managing the overall implementation. Product vendor Phase Forward provided training on Clintrial to all users at Veeda’s global units while IBM India provided first class end-user training and a thorough understanding of the product’s functionality to Veeda’s global teams. “There is ongoing development of Phase 1 ClinOne and Watson LIMS to improve the overall platform and subsequent service offering to the clients. With the further development we are also constantly reviewing and updating the validation status of all software in accordance with FDA CFR21 part 11,” informs Shah.
Binoy Gardi, Co-Group Managing Director and Co-Founder of Veeda informs, “The selection of Clintrial was based on its proven track record in improving efficiency and thereby accelerating drug development timelines. Easy integration of external data enables us to provide the sponsor faster access to fully validated data.” He adds, “The implementation of Clintrial is expected to enable Veeda to focus on its core competencies in delivering high quality data and simultaneously pave the way forward for new CDM capabilities.”
Knowing the importance of IT to sustain in the market Wanbury has also strategised their growth plans accordingly. They first implemented SAP as the business transaction system in January 2005 covering finance, inventory, purchase, sales and production. Naik avers that after implementation in 2005, they are improving and reconfiguring SAP every year to have better control over the business process or when the business process changes, and map SAP business flow to those changes. In 2006, they implemented HR software which will give consolidated view of the employee database and last year, they implemented a business intelligence (BI) Tool from which they can directly generate reports from various databases including SAP, which helps business users to analyse the data. He adds, “We will be implementing the latest version of SAP (ECC 6.0) and palm top based reporting and expense reporting for field people. We normally spend 1.5 percent of total turnover on IT in terms of new technology, new hardware and network component and new software. Wanbury knows that IT will play a big role in the rapid growth that we are planning and Wanbury’s management encourages the IT (department) to implement new and affordable technology as quickly as possible.”
All said and done, the whole process of implementation is not that easy. It not only requires investment of money and time, but for the whole procedure to be a success it requires proper training of the staff as well. Speaking about challenges Naik informs, “Challenges were for mapping the business process with software or sometimes changing the business process in tune with the ERP and implementing those changes in the company.” Further, he said that user training was also one of the challenges and the management tried to create super users in all functional areas. Extensive training was given to the business users for SAP transactions and reports and training was given to IT people for SAP support and reports development through BI Tool.
“We have a breed of young and highly educated employees having prior experience and knowledge of IT and computer related subjects. Further, we do envisage training for those who are not so proficient, needing further learning as investment in IT initiatives bring in huge returns. In addition, control and monitoring is achieved with greater ease leading to better corporate governance and transparency,” Gopinath voices. He adds that in a new enterprise, IT implementation is far easier as compared to existing companies because in the latter, the management has to face employees’ resistance to change, the fear of IT implementation leading to loss of jobs and being held accountable for a temporary dip in performance till the employees work out the best way to make the system function smoothly.
On the same lines, Gardi imparts, “Extensive vendor and in-house training has been provided to Veeda staff for all software. The training sessions lasted for about three-four days which have been documented and certificates have been provided to the trainees. The software has been well received and is running successfully at Veeda’s global locations.”
Gopinath concludes, “Since all our employees are adequately trained and exposed to computer applications and networking, the implementation process has been very easy and rewarding. In any initiative, what is more important is inclusiveness of the users to derive maximum benefits and speedy solutions.”