Patient rights, welfare and safety are of primary importance in the process of conducting clinical trials. ProTrials collaborates with established strategic partners for pharmacovigilance and medical monitoring services to meet your medical safety service requirements. For patient protection as well as data integrity, our project team members review patient safety data throughout the trial through Adverse Event (AE)/Serious Adverse Event (SAE) or Adverse Device Event (ADE)/Serious Adverse Device Effect (SADE) monitoring and review of endpoint data. Our team is equipped to analyze safety data and write Development Safety Update Reports (DSUR), updated clinical investigator brochures (IB), and patient safety narratives, as well as expedited safety reporting to regulatory agencies and distribution of IND Safety Reports or Suspected Unexpected Serious Adverse Reactions (SUSAR) to investigative sites.
Therapeutic Expertise When You Need It
ProTrials’partner physiciansbringdeep therapeutic expertiseto provide a full range of medical monitoring supportand related services for your project.
– 24/7 medical monitoring coverage
– Therapeutic training
– Medical team representative lending protocol or program expertise
– Protocol, informed consent, and case report form (CRF) design review
– Regulatory advice, counseling, and support
– Clinical investigator brochure (IB) development
– Laboratory data review
– Medical data/listing review
– Medical coding
– Medical writing
– Safety review and consulting
– Data Monitoring Committee (DMC) / Data Safety Monitoring Board (DSMB)coordination and meetings
– Communication with key stakeholders and influencers
Regulatory Affairs in Order?
ProTrialsis dedicated to confirming thatsites completethe applicable regulatory documents (and have a fully executed clinical trial agreement) prior to site activation and throughout the study. Our highly–trained team reviewsregulatory document packagesfor accuracy and completeness, and supports studies ranging in size from a single investigational site to large, randomized clinical sites – both domestic and international. In addition to regulatory document review, tracking and maintenance services for your essential project,we also file these documents in the electronic Trial Master File (eTMF).
Through global strategic partnerships, experts will assist you with a full suite of regulatory support including submissions to regulatory agencies. ProTrials is current on all communications from the FDA and international regulatory authorities, including new guidelines and recommendations. We provide trainingon an ongoing basis to our staff on revised or clarified regulatory information and ICH GCP guidelines.
Virtual and Decentralized Trials
ProTrials leverages virtual trial technology solutions and remote monitoring strategies to improve safety and help put lifesaving clinical trials into action.
