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Saturday, 15 June 2013

Technology in clinical research creates both challenges & opportunities: Expert

The pharma industry covering contract manufacturing services and specifically the research services and clinical trials segment need to adopt technology and this is seen as the only way to simplify operations, carry out processes efficiently and save time.
The key benefits of ‘Technology in Research’ are that it helps to compress timelines, narrow the pipeline of extensive drug development period that spans anywhere between seven and 15 years. There is also the economies-of-scale in terms of cost and time which provide overall efficiency, said Bindhya Cariappa, executive vice president, Global Clinical Research, ClinTec International.
There would also be reduced resource requirements, higher quality, compliance and access to real time information, said Cariappa at the recently concluded Golden Jubilee event of the Government College of Pharmacy.
Clinical research technology provides process management with clinical research companies accessing trial management systems and safety management. There is the combined scientific and regulatory expertise with innovative technology to deliver reliable consulting services and practical electronic solutions that ensure the patient’s voice is heard during new medical product development via the  Interactive Voice Response System (IVRS) combined with ubiquitous phone and fax services, or an Interactive Web Response System (IWRS).
With the FDA issuing the final Guidance on Patient Reported Outcome Measures in 2009, it endorsed the use of patient reported data is complied into the electronic diaries and PRO or patient reported outcome assessment. Data management which is a critical component in clinical trials calls for use of case report forms (CRFs) and electronic data capture (EDC) besides use of analytics such as SAS (Statistical Analysis System) and SPSS (Superior Performing Statistical Software). There is also the need to access the e-library like the MedDRA, WHO Drug, ICD, said Cariappa.
There is also need for research technologies like the Clinical Trial Management which helps to plan trial processes, timelines, resources, budgets and track preparation and performance. Some of these process management solutions are IMPACT & Trialworks (Perceptive), ClinTrial & Sieble (Oracle), Study Manager and Office Smart (BioClinical).
The companies also need to have systems of Safety Management in place to help capture, detect, assess, understand and prevent adverse reactions of investigational product. Some of these products are Argus (Oracle), Total Safety & ARISg (ArisGlobal).
Further, the Interactive Response technologies like the voice based (IVRS), and web based (IWRS) are implemented to allocate randomized treatment to clinical trial patients. It also helps flexible and efficient medication allocation. All these are efficient patient targeted technologies utilized to ensure transparency in the clinical trial protocols, said Cariappa.
Therefore investment in technology allows a constant tab on patient reported outcomes and compliance. Further, it helps to plan, capture, verify, control and organize data. Besides it also assists in data sorting which is utilized for organising and reporting medical events during trials and the maintain records of medications administered. While there would be a number of challenges in the technology adoption, the benefits are much more for a segment like clinical research, she stated.


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