Safety reporting and pharmacovigilance services include: SAE management, Data Safety Monitoring Board (SRC) coordination and management, trend and signal analysis, safety reviews, safety reporting, and coding and coding reviews with experienced and professional personnel. Whether an entire project team or a single professional is required, clinCORE sets the standard for providing high quality, flexible and efficient solutions for today’s clinical research outsourcing needs.
Timely and systematic collection of information from multiple sources
Pharmacovigilance professionals with a broad range of clinical assessment skills provide appropriate causality assessment for each adverse event
Early indication of potential safety issues with real time monitoring of your safety data
Additional Services :
Our full suite of medical consulting services includes protocol development and review to ensure sensible design and appropriate patient safety, case report form review, interaction with safety and advisory committees, statistical analysis review, and analysis of trends or clinically significant events. Our physicians can serve as a medical liaison to any member of the investigative team.
Our team of physicians is accessible to investigators, team members, and sponsors 24 hours a day via cellular phone or email. We assign one physician to each study as the “primary team member,” and a second physician, who is also fully familiar with all aspects of your project, to assist you when the primary physician is not available.
Our physicians fully monitor and participate in all phases of each project, including interactions with investigative sites regarding protocol interpretation, inclusion and exclusion criteria for patients, assessment and management of medical and laboratory data, and noted safety issues that arise during the course of a clinical trial. This service is available to investigators and the study team 24 hours a day.
Serious Adverse Event (SAE) Management
We offer full SAE management—and ensure strict adherence to all related regulatory guidelines in clinical trials and for postmarketing. Our drug safety personnel have handled SAE management at all phases of clinical trials, and have worked on trials of various sizes. They have worked in a variety of therapeutic areas, and have first-hand experience entering safety information into sponsors’ databases.
We offer full SAE management and ensure strict adherence to all related regulatory guidelines. Our drug safety personnel collect the required data, prepare the serious adverse event narratives, provide sponsor comment, reconcile adverse event and serious adverse event databases, and monitor trends within a protocol or subject population. We work closely with your company’s medical group to assess your needs and ultimately bring you the product you require, in the style that best fits your company.
Coding and Safety Reviews
Our medical team will review coding reports to ensure that each term is coded properly and consistently throughout the study. The team will also review adverse event listings, SAE listings, concomitant medications, procedures, laboratory results, and physical findings to ensure that all safety data is captured appropriately and to review for signals or trends.
Literature Search, Review and Assessment
Our literature search team will determine parameters for literature e-searches by working closely with each client and then program the searches to verify that the highest quality data is provided. The medical team will review all findings to determine the relevancy of each finding and if appropriate, report these and provide medical assessments for the case.
Data Safety Monitoring Boards (DSMB) Management and Participation
We can provide management of a DSMB to include recruiting and contracting members, creating charters, organizing and running all meetings, capturing all meeting details and providing assessments from the DSMB.
Safety Monitoring Committee (SMC) Management and Participation
We can provide management of a SMC to include recruiting and contracting members, creating charters, organizing and running all meetings, capturing all meeting details and providing assessments from the SMC.
Medical Writing Services
Using our in-house experienced medical writers and our experienced physicians, we can prepare and review a variety of regulatory documents and IND and NA submissions. Additionally, we regularly support final study reports, periodic safety updates, annual reports, etc. for investigational and post-marketing trials. Our personnel write narratives for patients who discontinue use of a drug due to adverse events (AEs), experience laboratory abnormalities, or experience clinically significant events that require clear documentation for inclusion in the final study report.
We can prepare and/or presents medical and safety information—including the protocol, safety procedures, and the process and importance of collecting appropriate data—at investigator meetings. We firmly believe that an early investment in training the investigator, study coordinator, and support staff in protocol review and data collection results in a more concise, accurate and presentable end product.
We customize and present training materials specific to your study for both your team and the CROs. Our team training program includes a medical overview that clarifies the study protocol, and SAE reporting training to guide your team through the necessary steps to create accurate reports. This specialized training will increase your team’s understanding of the study data—allowing them to judge the information they receive more effectively and efficiently.