Business Accent

Clinical Data Management Solutions

There is an impending need for integrated IT solutions to document and speed research and clinical trials. George Varghese discusses what to lookout for in an IT solution

The life sciences arena is complex: Healthcare providers, health insurance companies and biomedical companies, including pharmaceutical, biotechnology and medical device firms, face tremendous pressure to reach their own organisational goals and also face competition from others.

Each sector plays a vital role in the health care process, from the inception of a drug and bringing it to the market successfully, to delivering evidence-based outcomes and covering the cost of the claim. At the same time, escalating costs, tighter budgets and the pressure from regulatory agencies, shareholders, and consumers have never been greater. In such a situation, it is imperative that life sciences executives make intelligent decisions quickly and efficiently. However, they can only do so if they have the utmost confidence in their clinical data management and biostatistical information and processes.

But with clinical trials data scattered among different systems throughout life sciences research organisations and new data arriving almost continuously from electronic data capture (EDC) vendors, contract research organisations (CROs) and other research partners, bringing new therapies to market by itself is extraordinarily complex.

Therefore, the question is, how can life sciences companies fully integrate and analyse their research for regulatory submission and identify new market opportunities and product line extensions, while addressing potential safety issues more efficiently and effectively?

It will help if a co-ordinated approach to the life sciences industry is taken by organisations to meet their specialised needs, while recognising the benefits of understanding their partners, suppliers and customers. Business Intelligence Solutions for life sciences should deliver technology and industry expertise that facilitates information integration and knowledge sharing and should further enable a continuous dialogue between life science organisations.

A Sole Solution

Research companies, today, need a total, integrated Clinical Data Management solution that includes technologies, methodologies and people with a proven success record. They need a web-enabled information platform to remove the obstacles in sharing data and applications across organisations and deliver the foresight and understanding required to succeed. This platform should serve as the centralised repository that allows life sciences firms to analyse their clinical research for regulatory submission and explore new market opportunities, product line extensions and safety issues - all within a controlled and secure collaborative framework designed for life sciences research industries.

The platform should also provide a robust data entry portal, integrated with the ability to handle data transformation, data imports and exports, analysis and reporting. It should serve as a flexible management solution, which enables any kind of sharing of web-based information and should follow the de facto standards in the life science industry for data management, analysis and clinical trial reporting.

The solution should be efficient and simple and should meet all regulatory requirements, as well as, provide a sole solution for the entire clinical research process.

By following data from the moment it is entered, it speeds up the entire clinical research process. In addition to this, a Clinical Data Management solution should be customisable to meet federal regulations such as 21 CFR Part 11, good industry and sound business practices. It should also integrate a number of key capabilities into a single, compliance-enabling solution for managing, analysing and exploring clinical data.

The solution when used in conjunction with data from third-party sources like EDC, laboratory and safety systems, should enable users to conduct the statistical analysis required for techniques like adaptive trials, signal detection and pharmacovigilance. It should enable focusing on reducing costs, accelerating decision-making processes and achieving operational efficiencies.

Any solution of this nature should be part of an Enterprise Intelligence Platform (EIP). The EIP should enable superior data warehousing, analytic, reporting and exploring technologies that help turn vast amounts of data into the kind of intelligence demanded by decision makers, who need to respond quickly with the right decisions.

The author is the Head Marketing & Alliances, Pharma & ITES, SAS India