31 January, 2012 Patricia Santos-Serrao, Senior Product Manager, Pharmaceutical Industry, MasterControl
One of the most costly areas of business for any Pharmaceutical or Biotechnology Company has always been clinical research. Now more than ever the cost of bringing a product to market is staggering and as patents on trademark products expire the hope for recovering costs of research get smaller and smaller.
According to cutting edge Information, a pharmaceutical and biotechnology research firm, the per patient costs of a clinical trial in the past three years (2008-2011) has increased dramatically and in most cases has more than doubled (see Table 1 below).
Table 1: Per Patient Cost of Clinical Trials (2008 - 2011)
|Per Patient Cost of Clinical1
That being said it is no surprise that companies are looking to streamline their processes and where ever possible cut costs. Some ways that companies have managed to do that is by implementing solutions that increase efficiency, reduce risk and increase compliance. Below are some examples:
|Clinical Study Document Management
- Increase Efficiency and Accuracy of Information
- Reduce Site Start-up Time
- Increase Information Exhange with Sites
- Implement Standard Best Practices (i.e., DIA TMF Reference Model)
|Site Relationship Management
- Reduce time to find eligible sites for Trials
- Up-to-date information on sites facilities & equipment
- Up-to-date investigator and site documentation (i.e., CV, 1572)
|Process Compliance & GCP Auditing
- Ensure completeness of GCP Processes: Trial Initiation, and Trial Closeout
- Close Loop on GCP Audit and/or Clinical CAPA: Internal, CROs, and Sites
- Information approval and sharing can be instant
- Reduces lose of detailed information
- Investigators can access and enter information instantly (smart phones, tablets, etc.)
For more ideas on improving efficiency and reducing cost in clinical research feel free to contact your MasterControl account executive.
Patricia Santos Serrao, RAC, is a Life Sciences professional with almost two decades of experience in Regulatory Affairs and Clinical areas of the Pharmaceutical Industry.
Prior to joining MasterControl, Patricia held the position of Manager, Global Regulatory Solutions for QUMAS, a company specializing in quality and compliance management software for Life Sciences, where she helped drive the development, sales, marketing and implementation of solutions for the R&D areas of the Pharmaceutical Industry with a particular focus on submission document management for Regulatory Affairs, and Clinical Trial Master Files (CTMF) for Clinical.
She’s worked for several Tier 1 pharmaceutical companies, including Schering-Plough and Boehringer Ingelheim, both in Regulatory Affairs and Clinical. She’s assisted various pharmaceutical, biotechnology and medical device companies in implementing electronic document management and submission solutions, and in compiling eCTDs, and other submission format filings worldwide. A graduate of Western Connecticut State University and University of Phoenix, Patricia holds a Bachelor’s of Science degree in Business Administration. Patricia is a member of Regulatory Affairs Professional Society (RAPS) and Drug Information Association (DIA). She has also earned her Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) and the Regulatory Affairs Certification Board (RACB).