Oracle Clinical Implementation for a CRO
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 ICH-GCP (International Conference of Harmonization-Good Clinical Practice) 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.
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.
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 the redundant data had to be tackled
Infosys' five-member onsite team 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 IQ, OQ, and PQ (installation, operational, and performance qualification) scripts to confirm the compliance of the solution with industry standards and to check the robustness of the new system.
Thanks to Infosys' project and time management skills, the entire project was completed onsite on budget and on time.
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 Infosys' study of the systems and processes 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