Safety is imperative in clinical trials – new drugs and devices, no matter how innovative, cannot get to market unless proven to be safe for those who will use them.
Our Safety Surveillance team provides customized solutions to pharmaceutical, biotechnology, and medical device companies to effectively track and manage their products’ benefits and risks throughout the product lifecycle. We can provide our clients with end-to-end clinical safety services from early phase through approval and post-marketing in 2 ways:
- As part of a full-service project
- As discrete, standalone offerings.
Experienced Staff Provides Clinical Safety Expertise
With expertise across multiple therapeutic areas, our safety staffs of highly trained professionals (including MDs, PharmDs, and RNs) is well versed in safety reporting practices and regulations. Our flexible infrastructure allows us to adapt to your specific safety needs, from case processing and medical evaluation to submission of safety data to regulatory authorities. Sponsors select the level of involvement in the clinical safety process suitable for your company and available resources.
Efficient Technology Enhances Your Study’s Performance
ProRelixResearch utilizes advanced software solutions for its safety database technology platform: Argus Safety and Argus Interchange. ProRelixResearch can offer Argus Safety as well as migrate safety data from legacy or discontinued systems.
We also utilize a validated, industry-accepted electronic gateway, Interchange platform, in conjunction Safety with Argus. These technologies support safety surveillance for drugs, biologics, vaccines, and medical devices throughout the product’s lifecycle offering:
- State-of-the-art technology backbone with a clean interface, strong redundancy and an efficient configurable workflow to support evolving client needs – used for full-service projects
- Argus Safety database allows hosting for clients who do not have their own safety database and technology infrastructure
- Our system facilitates secure submission of regulated data, such as individual expedited safety reports (ICSRs/SUSARs), to the FDA and health authorities in standardized ICH formats
In addition, such technology allows for rapid exchange of safety data among marketing partners, affiliates, and/or vendors while ensuring the integrity of the data. You will have timely access to your data.
Safety Surveillance Services Are Tailored To Your Specific Needs And Include:
- Safety Surveillance support for standalone contracts as well as full service
- Product safety consulting (clinical and post-approval)
For a full overview of our suite of full-service and standalone safety surveillance services, contact us today to speak to our safety services experts so they can answer any questions you might have.