Monday, 21 January 2013

Importance of IT in Clinical Research Industry

The process of drug development and approval process takes a lot of time and is an expensive process. Generally, this process requires millions of dollars in investments and takes many years to complete.
Why the drug does takes more than 15 years to be launched into the market?
Since the drugs goes through different stages staring from lead discovery till marketing and each stages of drug discovery takes almost more than 2-3 year as a result of which the total years of drug discovery gets extended to approximately 10-12 years

Successful process takes

  •     More than 10 years
  •     More than $800 million – $1.2 billion
  •     More than 10000 tested compound
  •     For one drug
 Figure 1
Pharmaceutical and life sciences companies are outsourcing more of their activities to the IT Companies in a proposal to improve Research efficiencies and shorten the drug development timeline.
IT Players in Clinical Trial:-
  • Accenture
  • HCL
  • Reliance
  • Cognizant
  • TCS
  • Wipro
  • Infosys 
Roles of the IT player:-
The IT Companies play major role in reducing the cost of the clinical trial by decreasing the timeline of approval process and increasing the efficiency of the trial by delivering accurate and reliable data. 
So, Pharmaceuticals companies are increasingly looking for partners to sustain them in their revolution, to optimize costs, and to bring innovation to the field of clinical research.
In what ways the IT Companies provides support to pharmaceutical industry?

  1. By designing electronic capture instrument which facilitates the capture of massive amount of data generated during the conduct of clinical trial.
  2. By designing and ensuring the testing (UAT)and validation of each and every process involved in design of the database.
  3. Designing different dictionaries based on the requirement of client to enforce standardization as per the regulatory.
  4. Provide support for data communication.
  5. Provides confidentiality by ensuring security.
  6. Furnish a mechanism to ensure that only authorized users can have access to the database.
  7. Providing the opportunity to the Pharma companies to implement the existing standards and regulation.
  8. For example, Title 21 Code of Federal Regulations under the FDA defines the guidelines for.
    •   Electronic records.
    •   System validations.
    •   Processing of electronic data and signatures to demonstrate compliance with paper records.
  9. By Offering real time web based reporting to client. 
  10. By offering online reporting system to enhance and fasten the reporting of any SAE appearing once the drug is being marketed.
  11. By bringing efficiency to its US sales and marketing operation, through a range of solutions spanning commercial analytics, sales force planning, sales incentive compensation, customer relationship.
  12. Furnish a mechanism for recovering the database if the database is damaged in any ways.


 The data management processing not only improves the overall cost of the clinical trial but also enhances the sharing and integrity of the clinical data .Henceforth reducing the redundancy.

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