IT plays Vital Role in streamlining CRO Operation

IT plays Vital Role in streamlining CRO Operation

Use fo IT can help CROs streamline its functions and focus more on their core Activities.

Information Technology offers CROs the opportunity to streamline the clinical trial process by speeding the transmission of results between physicians, researchers and sponsors, and to improve the quality of information available to patients and others.

Use of IT helps clinical trials expanding in functionality, integration, and ease of use, considerable improvements to clinical development processes and timelines can't be far behind. Eectronic data capture (EDC) and data mining are need of the hour for CROs.

The present state of clinical development remains largely a paper-driven process that is cumbersome, time consuming, and costly. Geographically dispersed stakeholders performing internal protocol review via paper copies delay study startup. Paper-based monitoring and reporting of adverse events slow response time. Response time and quality suffer, and data are not visible to the sponsor in real time.

Important metadata cannot be easily generated, and there is no simple way to search data to highlight problematic investigative sites or facilitate decision making early enough to make a difference. And whether trial data are stored electronically or with paper, they tend to be stored in incompatible systems and formats that complicate data entry, data exchange among stakeholders, query resolution, and data reconciliation during the trial and before database lock.

Adopting IT solutions is very crucial for CROs as the information is a very critical resource in their operation. Also their is a need of such IT solutions that enable them to key in, analyse and interpret volumes of data and report as per the standards laid down by the regulatory bodies.

A CRO needs IT solutions in areas ranging from data management, clinical trial management for statistical analysis, data backup and so on. Further, IT-based solutions are required for maintaining database of investigators, trial material inventory management and for enabling collection of data from subjects through various electronic gadgets, such as patient diaries and programmed electronic devices.

The promise of IT to help streamline clinical development is perhaps best understood by defining its impact on the seven core functions of clinical development . Those functions figure prominently in the lengthy sequence of events beginning with sample submission and protocol approval, moving to patient enrollment, trial management, database lock, statistical analysis, report writing, and finally, regulatory submission. Each step along the way is fraught with challenges related to inadequate or an absence of technology, or the mixed use of electronic and paper-based methodologies.

Seven Core Functions—

Targets for Improvement
Protocol Design and Study Start Up
Patient and Investigator Recruitment
Clinical Trial Management
Clinical Data Management
Data Analysis
Clinical Supplies
Regulatory and Safety

However, it is always not an act of wisdom to implement IT solutions just because it is the today's buzzword, but the it should be a strategic decision. So that it can help CROs streamline their processes. Also, the investment made by CROs can range from Rs 50 lakh for basic systems to a few crore. Hence, any kind of IT implementation needs to be backed by sound thinking and a prudent rationale.

IT implementation is not just installing the necessary software on a machine. It starts with detailed need analysis and ends with comprehensive training. Otherwise, it can backfire resulting in the organisation finding themselves indisposed of IT .

s.junaid@kleward.com

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s.junaid@kleward.com
http://www.kleward.com

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