ACT accelerates clinical trials

Pharmaceutical companies spend 37 percent of their R&D budgets on speeding up clinical trials. A large part (30 percent) is outsourced to Clinical Research Organisations (CROs) who are looking at solutions that help automate the clinical trial process. Getting a new drug to market can cost as much as $500 million and take up to 15 years. Nearly half that time is spent on clinical trials. This is an area that is ripe for e-business applications.
Asian Clinical Trials (ACT) a Hyderabad-based Clinical Research Organisation popularly known as ACT has a large complement of experienced and well qualified research professionals representing a wide range of therapeutic areas and research functions. ACT has successfully conducted or collaborated, on significant research trials, with pharmaceutical and biotechnology sponsors and major CROs of the USA, UK, and India.

Out with the manual system

One of the key challenges for ACT was to manage and automate thousands of clinical trial processes of testing and reporting on safety administered by the US Food & Drug Administration (FDA). As per FDA regulations a computer generated, time-stamped audit trail of operator entries and actions that create, modify and delete records has to be maintained. Secondly, US pharmaceutical customers want their CROs to use a system, which is in compliance with 21 CRF Part II as laid down by the FDA.
The legacy system used by ACT did not have some key features to eliminate or catch errors during the data entry process. ACT had to manually take printouts and cross check with CRF pages. After the validation of software, query resolutions (mistakes or errors and certain queries which were in the CRF pages) had to be generated manually in Word. Data was then exported to an Excel sheet that was not secure.

A pre-fab solution

ACT did two trials before finalising on Oracle Clinical. There were two distinct advantages of using Oracle Clinical over other packages. Sunder says, "Local support is very crucial for our kind of business. We cannot afford to delay delivery as it will cost millions for our customers. Not many vendors have local support available in India and in many cases people have to come from outside India for resolving problems. Then there were problems with integrating a database with the application. Oracle Clinical comes with a database." In all one project used to take eight months to Execute. With Oracle Clinical 4.5.0.0 the mistakes are automatically tracked with double data entry. "This automatically creates a log of activities within Oracle Clinical. On getting a Response from the investigators, we close the query resolution file within Oracle Clinical after updating the data," says Sunder. Oracle Clinical has multiple levels of security, which ensures that a data entry person cannot change the data; a person resolving Queries cannot view data for which he does not have authorisation. A reviewer need not change the data and also create a complete log of activities right from the beginning of the study till the job is completed as logging is automatic.

Mission accomplished

In mid-February 2004 ACT raised a purchase order for Oracle Clinical. Infosys was engaged for implementing it [Oracle Clinical 4.5.0.3 Version] and the company trained ten people from ACT on Oracle Clinical and the process was completed in early March 2004. ACT went live with Oracle Clinical on 12th March 2004. A Dermatology project undertaken post-implementation of 6800 CRF pages (680 patients with 10 pages per patient) got executed in 18 days flat. The time taken for building the fully validated database using Oracle Clinical took about nine days and the double data Entry process took another nine working days.
Revving up
After implementing Oracle Clinical, the CRFs were built using Oracle Clinical at the time that the database was built and all security levels were set up. The software takes care of setting the security levels. The event log is generated by Oracle Clinical and the audit trail helps verify system integrity. Sunder says, "Prior to the Oracle Clinical implementation we have executed three projects [involving data management] in two years. Post implementation [Oracle Clinical] we have done three projects in four months. This is the Return-on-Investment."