Realtime-testing
Best-In-Class Pharmacovigilance and Regulatory Provider

In 2010, the key consultants co-founded Real Time Trials, bringing together the technologies (PV-SuiteTM) and pharmacovigilance operations and consulting skills. The establishment of Real Time Trials allows for the use of significant multinational pharmaceutical R&D, medical affairs, and business knowledge. Today, that expertise distinguishes Real Time Trials from other drug safety service providers, and it is viewed as a highly desirable value-added reason for clients to choose Real Time Trials.

The Real Time Trials service is primarily targeted at small to mid-sized biopharmaceutical and medical device companies, where the cost of meeting the increased regulatory and legal burden of monitoring product safety during clinical trials and post-marketing necessitates the use of a cost-effective and dependable global drug or device vigilance system. Real Time Trials’ expert expertise, technological platform, and commitment to exceeding regulatory requirements ensure that clients receive a completely compliant and reliable safety system at an affordable price. When dealing with clients, the firm makes the following promises: Accuracy: Ensuring that critical safety issues are identified quickly and that high-quality analyses and remedies are produced. Reliability: Constantly checking quality objectives to maintain industry-leading compliance metrics. Finally, there’s Integrity.

Real Time Trials combines cutting-edge pharmacovigilance database software with industry-leading specialists to help pharmaceutical companies achieve their regulatory obligations to monitor drug safety both before (clinical trials) and after receiving approval from competent authorities (post-marketing surveillance). Real Time Trials was designed by experts who spent a lot of time working for various pharmacovigilance departments and realized that there has to be a better and more effective way to navigate through the process based on the knowledge they gained. A mix of experience-into-practice methodology and field-proven tools gives Real Time Trials an edge.

Patients can benefit from Real Time Trials’ services throughout the whole drug safety workflow, from designing and implementing pharmacovigilance structures and processes to assisting in the delivery of an optimized safety system that ensures patients can meet their legal requirements. Real Time Trials can offer advice on in-house implementation or supply patients with a smart and efficient outsourced safety service. Real Time Trials stands out from other service providers in the sector due to its competence in medicine R&D and post-marketing assistance. Real Time Trials focuses on three areas of need: clinical trial safety, post-marketing surveillance and design, and pharmacovigilance process and strategy advice.

Real Time Trials uses specifically designed pharmacovigilance and device-safety software and database set to deliver our outsourced services. Real Time Trials’ main safety database is PV-Suite™, a leading product recognized by numerous regulatory agencies worldwide. PV-Suite is a process-driven pharmacovigilance software solution that complies with all worldwide regulatory requirements, including the FDA’s 21 CFR Part 11 regulations. Client business processes are implemented using the software, which ensures SOP compliance and timely reporting. Process-driven “To-do” lists are generated by an integrated workflow engine. This provides complete control over pharmacovigilance operations, as well as extensive safety functions.

The software allows for detailed data entry and maintains a complete audit trail of all entries and changes. Data fields are evaluated as soon as they are entered, including semantic checks (range checks and cross-field checks), making MedDRA coding a breeze. Each case that is entered has full eCTD management, with all associated communications and reports loaded, guaranteeing that each documented case has a comprehensive and visible document history. Every E2B data field translates to a corresponding database field in the pharmacovigilance database, which was created according to the ICH E2B guideline.