Clinical Trial ManagementLooking to bring a new medical device to market? We can help.
Clinical trials are the critical step between developing a new medical technology or product and getting it approved by the FDA for market. Successfully managing a clinical trial requires expertise and experience in navigating a labyrinth of clinical and regulatory compliance requirements: developing, managing, and submitting to essential documentation, and providing seasoned trial monitoring of data to ensure patient safety and data accuracy for successful outcomes.
Our clinical research team is highly experienced in developing and supporting clinical trials to help ensure their success. They work closely with our regulatory specialists to help create a clinical strategy that is most appropriate for your product and its intended use.
Our clinical trial management team has years of experience in managing all aspects of a trial, from study feasibility to close-out. Our structured, proven approach produces timely, efficient, and successful project outcomes.
Our services include:
Study Feasibility is one of the most critical steps to identify and select sites that are the right fit for your specific study. Our team has worked with hundreds of investigators and sites, enabling us to identify the best ones for conducting a successful trial in your therapeutic area. We can also help with GLP animal studies to ensure early safety and efficacy.
Our team has a long history of relationships with regulatory authorities and IRBs, domestic, international, local, and centralized regulatory and/or IRB/EC submissions. Our team members have broad experience in protocol design, endpoint identification, input into inclusion/exclusion criteria, statistical and safety planning, data collection (eCRF), and EDC design. We create Informed Consent Form(s) (ICF) and Patient Recruitment Material, and we provide electronic Trial Master File (eTMF) support. We also proactively work with sites to manage budgets and contract negotiations.
Clinical Project Management
Our trial management professionals are fully committed to your clinical trial. Their focus is on timelines, budgets, clinical outcomes, and closely collaborating with your sponsors to ensure that all critical milestones are met. We manage study reporting, adverse events, protocol deviations, and data entry/query resolution metrics to keep you informed of your clinical trial progress.
Clinical Trial Monitoring
Monitoring is essential to ensure patient safety, especially in today’s remote clinical trial environment. MEDIcept can provide both onsite and remote monitoring, as well as oversight of sponsor and investigator site files to ensure compliance with industry expectations and regulatory standards.
Whether it’s providing additional support to your team or designing a turnkey clinical trial program, our experienced, knowledgeable experts are ready to partner with you to develop a clinical program customized to your needs.
I need help NOW!
Have you received an FDA 483 notice or a warning letter? Are you struggling to meet new EU MDR or EU IVDR regs? We can help you respond quickly and effectively to help prevent a difficult situation from getting worse.
Need FDA or EU MDR/IVDR audit assistance?
Don’t go it alone. Our deep, firsthand experience with FDA and EU MDR/IVDR audits can help you minimize risk and business disruption.
Are you a start-up?
We’ve helped a wide range of start-ups develop effective regulatory strategies to obtain FDA and EU MDR clearances. We’ll work with you to develop an appropriate domestic or global regulatory strategy to help ensure compliance and product approvals.