Technological advancements in the field of Life Sciences combined with the power of supercomputing is paving the way for unforeseen breakthroughs in understanding human health. Concerted international scientific effort has facilitated amazing feats in hearing implants, plant genomics and animal cloning. The prospect of human cloning, although against a groundswell of public opinion, is the next big discussion. As a result research findings and information repositories are rising exponentially, and today's scientists are increasingly relying on advanced technology to store results and execute research on a high-throughput basis.

The Life Sciences Industry
The life sciences industry is a rapidly growing segment involving highly complex R&D laboratories and vast scientific infrastructure. The industry spans organizations across Biotechnology, Pharmaceuticals, Bioengineering (enzyme, biotherapeutics), Diagnostics, Environmental biotechnology, Agro sciences, Medical devices and Healthcare providers. An industry as wide and as penetrative is not without challenges; pressure points include:

•		Rising cost of research and marketing
•		Expanding regulations
•		Looming expiration of patents
•		Market competition to stay ahead

Focus - Pharma Companies
Pharma companies can be broadly classified based on the type of research they undertake. Some of them cater to the needs of global customers - manufacture a range of drugs and launch them in different countries under different brand names. The others serve a local customer base with specific generic brands. They face diverse challenges in the areas of R&D, manufacturing and sales based on the category they belong to. Significant challenges include:

R&D
•		Reducing the drug’s time-to-market
•		Managing data security
•		Patent filing as per FDA, GCP and other regulatory bodies
•		Staying current with a newer and wider array of IT tools to analyze the huge amount of research data
•		Conducting clinical trials through contract research

Manufacturing
•		Control over inventory & logistics and distribution costs
•		Control over expired drugs
•		Quality controls and regulatory records
•		Automation using ERP and instrumentation
•		Efficient control over operations

Sales
•		Knowledge of drug effects in different markets
•		Sales information - portals (marketing information)
•		Warehouse status – stock positions with expiry
•		Tracking of expired drugs - drug disposal
•		Market penetration

The Drug Discovery Lifecycle

Drug Discovery
Changing technology and scientific breakthroughs are making researchers more dependent than ever on the effective use of IT. One of the key challenges facing researchers includes extensive integration of data and applications. The pharmaceutical industry as a whole is in absolute need of greater efficiency throughout the R&D process. Initially, drugs were discovered unexpected, however in recent times, drug receptor interactions, combinatorial chemistry and molecular modeling have led the way. Traditionally, animals were used for pre-human testing – an expensive, time consuming and ethically questionable procedure.

In-Silico and In Vitro Drug Discovery Process
ADME (Absorption, Distribution, Metabolism, and Excretion) techniques help model how the drug will likely act in the body. They can be experimental (in vitro, clinical) using cellular tissue, or in silico, using computational models (executed over computers using the molecular targets and receptors in simulated environment).

One of the major challenges faced by the pharmaceutical industry is the need to reduce the time and effort involved in getting a drug to the market; the main segment of this life cycle being Clinical Trials.

Clinical Trial
A clinical trial (also clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.

An independent CRO (Contract Research Organization) provides committed research resources, which allow focus on the highest standards set by the industry. They include strict adherence to protocols, excellent clinical practices and complete and accurate documentation. The personal attention to details given by CRO and the ability to provide timely and proficient trials will speed up the whole process of clinical studies. Most importantly, CROs strive for a humanistic approach to research, while maintaining and ensuring the integrity of each study.

There are more than 200 CROs helping international drug companies in their clinical trials. Outsourcing of clinical trials to India is on the rise due to presence of a large pool of multiethnic and multiracial backgrounds.

Clinical Trials Outsourcing
Outsourcing of clinical trials to India is on the rise due to the presence of a large pool of multiethnic and multiracial groups. Previous experience has shown that patient recruitment is rapid in India, thereby simplifying the clinical development process significantly.

Diseases such as multi drug-resistant pneumonia, hepatitis B, diabetes, and some cancers are far more prevalent in India than in the West. Drug companies can save up to 30%-50% overall on the cost of conducting trials in India as compared to the West. An independent study by a global CRO concluded that India has one of the best subject return rates in the world.

Today, India is identified as a major resource center for conducting clinical trials and data management services. Its increased regulatory control and its acceptance of the ICH guideline for GCP further enhance India's reputation as a place to conduct clinical trials. Many CRO centers are well equipped with strong process compliances such as ISO 9002 standards. FDA also audits these for process and protocols.

MphasiS’ Scientific Domain Expertise, Readiness to Partner and Size and Stability to maintain ongoing support relationship has factored in critical integration tasks.

MphasiS Capability: Clinical Trials
In the clinical trials sector, MphasiS provides a range of solutions such as:

•		Integration of clinical and analytical data
•		Improvising data and process flow between various stakeholders
•		Sales force automation (PDA /Mobile Computing platform)
•		Compliance to industry standards - 21 CFR Part 11, GAMP, HL7, data integration and data security
•		Document management system
•		CDSIC application interface for existing research data
•		Workflow using Lotus Notes
•		Clinical trial management solution
•		Validation on electronic submission data
•		Customized reporting
•		Data mining using SAS or similar tools, and LIMS integration with CTMS or devices

Key Benefits to Stakeholders

Life Sciences Industry: MphasiS Competence
For a typical Pharma company, our services are as represented in the process map below. We cater to all data management requirements of organizations in this field.

Case Study