Clinical ResearchFor best results, trust us with your next clinical trial
Our team of experienced clinical operations professionals has the necessary expertise and understanding of the medical industry’s complex clinical trial development and management process to successfully support your clinical trial efforts, from concept inception, through all phases to post-approval. We integrate firsthand clinical expertise with a deep understanding of current regulatory requirements and client expectations to develop the most effective management plan and execution of the clinical trial for your successful product launch.
We offer customized study design and management based on your needs regardless of your product development stage. Our team of clinical trial professionals has extensive experience with first-in-human (FIH), feasibility, pivotal, long-term follow-up, post-approval, post-market studies/registries. First-in-human and feasibility studies are essential for early product experience and require stringent regulatory and safety oversight. Crucial steps for all clinical trials, but especially for our pre-revenue start-up clients.
Our clinical trial consulting services include:
- Protocol development
- Clinical trial design
- Site feasibility
- IRB/Ethics Committee management
- Site contract/budget development and management
- Study start-up management
- Clinical project management
- Clinical trial monitoring
- Data management
- Case Report Forms (CRF) design/development
- Electronic data capture (EDC) development
- Safety monitoring and reporting
- Statistical analysis
- Clinical Study Report (CSR)
- Site and vendor contracting and management
- Trial financial management
- Supply management
- Trial Master File (TMF) management
Study Feasibility is one of the most critical steps to identify and select sites that are the right fit for your specific study. Finding the best sites and investigators in your therapeutic area are invaluable for a successful trial. MEDIcept’s experienced consultants have worked with hundreds of investigators and sites. MEDIcept can also help with GLP animal studies to ensure safety and preliminary efficacy.
MEDIcept’s team of clinical and regulatory consultants have a long history of relationships with regulatory authorities and IRBs. We can assist with your domestic, international, local, and centralized IRB/EC submission. Our team has experience assisting in the protocol design, endpoint identification, input into inclusion/exclusion criteria, statistical and safety planning, data collection (eCRF), and EDC design. MEDIcept can collaborate with the client to create Informed Consent Form (ICF) and Patient Recruitment Material and provide electronic Trial Master File (eTMF) support. We proactively work with sites to manage budgets and contract negotiations.
Clinical Project Management
MEDIcept’s global project managers are committed to your clinical trial focusing on timelines, budgets, and clinical outcomes. We collaborate with the sponsors to ensure critical milestones are met. We manage study reporting, such as adverse events, protocol deviations, and data entry/query resolution metrics to keep you informed of your clinical trial progress.
Clinical Trial Monitoring
Clinical monitoring is essential to ensure safety oversight and patient safety, especially in today’s remote clinical trials 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. We review and discuss adverse event (AE) listings and report and follow-up with investigators on serious adverse events (SAE).
Internal/External Clinical Trial Audit and Inspections
MEDIcept provides remote internal and external sponsor and vendor inspections and audits to confirm compliance with industry expectations and regulatory standards. We can assist sponsors in preparation for audits and inspections, support them during the process, and, if necessary, provide oversight for corrective actions.
I need help NOW!
Are you struggling to get or keep a clinical project on track? We have the clinical investigation experience and expertise to help you minimize risk and avoid costly delays.
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?
Navigating the complexities of a clinical investigation prior to launching a first product can be daunting for a start-up. We’ll work with you to develop an effective domestic or global clinical strategy to help ensure timely product approvals.