Pharmaceutical and Biotech

Case Studies

Oracle clinical implementation for a CRO

The client

The client, Asian Clinical Trials (ACT), is a full-spectrum contract / clinical research organization that offers a wide range of services to guide pharmaceutical, biotechnology, and medical device companies to get their new products into the market faster. ACT provides clinical research (phase II / III / IV clinical trials) based on International Conference of Harmonization-Good Clinical Practice (ICH-GCP) standards and data management services to global life sciences corporations.

Based in Hyderabad, India, it has highly experienced professionals in the field of clinical trials. ACT meets the quality requirements of its customers with utmost professionalism.

Business need

In the field of clinical trials, large amounts of patient information are collected, sorted, and stored. Since this data is crucial for patient care, its accuracy, accessibility, and confidentiality are vital. Therefore, any IT system that is used to record clinical information must be secure, cost-effective, and foolproof. Dissatisfied with the performance of its existing data management solution, ACT decided to move to a more robust and scalable IT platform. Its international customers needed a higher quality of service, which demanded a more accurate and reliable clinical data management system (CDMS). ACT also wanted to strengthen its business offerings portfolio for potential partners. After consulting Infosys, it settled on Oracle Clinical 4.5 as the CDMS of choice.

Challenges

Clinical data management in itself presents considerable challenges, owing to the enormity of details involved. Apart from this, other challenges that the Infosys team faced were:

  • The existing system lacked a standard, centralized approach to design and set up clinical trial studies. This problem had to be addressed first.
  • As the data was confidential, the team had to ensure that the solution was effective and did not create issues of liability.
  • The usual challenges of replacing any heterogeneous, unscalable software with an off-the-shelf cutting-edge package had to be addressed, without implicating the cost factor.
  • The data had to be entered manually, which led to long delays and errors.
  • The team had to figure out how the new CDMS would relate to the legacy systems and how redundant data had to be tackled.

Our solution

The five-member onsite team from Infosys first focused on understanding the client’s needs thoroughly. They gathered detailed requirement information to build a system architecture plan and a validation plan to assure compliance with industry standards. An extensive training program was also planned and implemented.

Infosys began deployment by leveraging its proprietary implementation methodology to install Oracle Clinical 4.5 on ACT's systems. This was followed by the Global Library Setup of the package.

Next, the team built a pilot Case Report Form (CRF) for the client to use and test. Infosys then ran a data management pilot to assess and test the newly installed systems. The team also focused on putting in place the requisite metadata conventions.

Based on the validation plan, the team then ran the necessary installation, operational, and performance qualification (IQ, OQ, and PQ) scripts to confirm the compliance of the solution with industry standards and to check the robustness of the new system.

Thanks to project and time management skills of Infosys, the entire project was completed onsite within budget and on time.

Benefits

The new solution has enhanced the existing service portfolio and ACT can now ensure far better quality of services to its global customers. The specific benefits are:

  • It can now enforce global data standards and achieve rapid study setup
  • The total cost of ownership of systems has been significantly reduced
  • The knowledge gained from study of the systems and processes by Infosys enabled ACT to translate its business strategy into tangible results
  • The threat of loss of business knowledge posed by its legacy systems has reduced dramatically
  • The solution has enabled ACT to initiate discussions with multiple prospects

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