Services > Clinical and Investigator Portal

Speed up your clinical trial process through secure and efficient collaboration

 
Improving efficiency during clinical trial processes is one of the strategies adopted by Life Science companies to reduce costs and speed their products to market. And, as companies increase their global presence and outsource some of their business areas, the need for greater and more efficient collaboration capabilities becomes more essential than ever.

The traditional paper-based methods of document exchange, approvals and version management are very time-consuming and normally entail delays and high costs with express deliveries, storage and search of documents, among other tasks. On the other hand, online document exchange through e-mail or fax is not sufficiently secure.

Investigative sites deal with a growing number of studies from different sponsors, and therefore have to keep track of the documentation from each study. Trial teams, in turn, need to stay up-to-date on the progress of the studies in each site.

A web-based clinical portal can help improve this process. Designed correctly, it enables easy, cost-effective and secure document exchange as well as facilitates collaborative activities between internal and external stakeholders involved in clinical trials.

epista IT will help you implement the right clinical portal solution
When selecting clinical portal software, multiple aspects must be taken into account, ranging from security, quality and regulatory requirements to user-friendliness, and from investment and operational costs to integration with IT platforms and other systems, just to name a few.
epista IT can help you map and analyze all requirements involved in the selection of the right clinical portal solution for your business.  You can also count on our support for implementation and validation, using risk assessments based on GAMP best practices, 21CFR Part 11 regulation and ISO 14155:2011.

• Meet PMA submission and ISO 14155:2011 requirements with a clinical and investigator portal (only relevant for Medical Devices)
• The number of Medical Device submissions that are required to meet PMA regulations are increasing in numbers. What characterizes the core challenges for Medical Device sponsors and CRO’s is:
• - Difficulties of attracting qualified clinical investigator sites
• - Hard to monitor and influence clinical investigator sites
• - Keep track and legally control documentation of data, workflows and level of compliance.

• With the clinical and investigator portal the sponsor can provide:
• - Online training of site staff
• - Online supervision
• - Versioning of documents, protocols and contracts etc.
• - Online Review and Approval