Global Pharma Management

LONDON - Life sciences companies globally are turning to e-clinical solutions in order to improve inefficiencies and cut costs during the most expensive phase of drug development, says a new report.

The British market analyst Datamonitor claims that - on average - life science companies spend between $12-$17 million yearly on mailings and copies of paper case report forms With the implementation of e-clinical solutions, in particular electronic data capture and clinical trials management systems, a company could save anywhere from $10-$15 million a year on paper and postage alone, the report claims.

The report, titled In Pursuit of the Paperless Clinical Trial: A Look at EDC and CTMS, investigates technology solutions that will be integral to streamlining the clinical trials process. It concludes that firms spend nearly $1 billion to bring a new drug to market, of which $500-$700 million is spent on clinical trials. However, several pharmaceutical companies and CROs have already developed strategies to use EDC for 100 percent of their trials by 2012.

Ruchi Mallya, pharmaceutical technology analyst at Datamonitor and author of the study said, The adoption of EDC and CTMS solutions will be integral in enhancing and transforming the data collection and management aspects of a trial," said Ruchi Mallya, pharmaceutical technology analyst at Datamonitor and author of the study. An efficient e-clinical platform will provide companies with substantial cost and time savings and will play a vital role in changing the research process for the better. A comprehensive platform will also play an important role in promoting public health

Mallya believes the adoption of EDC will be rapid through 2012, at which point she said it would likely plateau. Mallya also predicted the industry would see an increase in the adoption of CTMS as management becomes a greater issue due to the globalization of clinical trials.

The report notes that there has been much talk of conducting adaptive trials as a means to accelerate the drug development process. Through this process, pharmaceutical and biotech companies have the flexibility to analyze study data before the end of the trial and change its design in order to either improve the chances for a better positive result or cancel the trial if the drug appears ineffective.

EDC allows for a centralized, standard workflow to easily collect, clean, validate and manage patient data. It provides real-time, permission-based access to high quality data, which is critical to a time-sensitive process in which only a limited user-base may be exposed to the data. CTMS provides a platform to track and manage all non-patient information related to a trial. A CTMS allows sponsors to maximize clinical supply usage based on patient enrollment of each treatment arm, which could change mid-trial.