There are many factors that come into play when deciding whether to employ electronic or paper data capture (EDC or PDC) for data management of a clinical trial. Most people focus on the perceived benefits of EDC, mainly relating to the ability to look at data on an ongoing basis. But there are other aspects that require consideration, such as set-up time, cost, and whether there are patient-generated data. These considerations are particularly important for small companies who run few trials, and therefore do not have in-house data management capabilities.

This presentation covers all aspects of EDC vs. PDC, describing the pros and cons of each for different situations. For example, what is the most cost-effective solution for a medical device company that runs one trial a year on average, has no in-house data management capability, and whose trials involve few patients, long follow-up periods, and patient-generated data? Conversely, what is the best solution for an in-vitro diagnostics company that performs large studies of several thousand patients with a very small case report form, almost no follow-up period, and the requirement to import large amounts of laboratory data?

This audio conference covers:

• A brief description of electronic and paper data capture systems
• Key factors to be taken into account when deciding on EDC vs. PDC
• The pros and cons of EDC and PDC in a variety of scenarios
• The questions you need to ask your EDC/PDC provider

About the speaker:

Helen Colquhoun is CEO of Pleiad Inc, a full service medical device CRO. She has worked in the medical device and pharmaceutical industries for more than 20 years. She is a physician with a depth of experience in vigilance, pharmacovigilance, regulatory affairs, clinical study design and management, and product development planning. Her expertise covers North America and Europe. She is based in Cambridge, Massachusetts.

Who should attend?

• Data managers
• Outsourcing managers
• Clinical managers
• Project managers