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, and 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 consulting services include full-service CRO for clinical trials, Medical Writing, Strategy, and Submission support services.
Clinical Planning and Strategy
The strategy and planning of clinical trials is dependent on the regulatory strategy such as the indication for use for the product, risk level of the product, and patient population. MEDIcept Clinical works conjointly with regulatory to define the clinical strategy most appropriate for your product and its intended use. Trials considered for pre-market clinical trials as well as post-market studies are:
Feasibility Studies/First-In-Human: critical for products/procedures that are high risk and/or have never been tested in humans. These studies provide important insight into the product’s safety.
Studies intended for Regulatory Submissions: whether pharma or device studies are intended to demonstrate the safety and performance of the product and are carefully designed to demonstrate statistical significance.
Post-Approval: mandated by the regulatory authority after an initial conditional approval is granted to assess long-term safety and performance.
Post-Market/Registries: intended by Client to ensure post-market safety surveillance, enhance the cleared or approved product with publications, or for marketing purposes.
We are skilled to prepare a clinical trial plan design, with accelerated but realistic timelines, and cost-efficient support for multiple types of products and studies from early phase to late phase.
Responsible for planning and executing clinical trials from protocol design and trial execution to patient safety support, to protocol compliance, data quality and timely dissemination of results. Together, our Clinical team has over 100 years of experience in complex studies conducted globally.
Clinical Trial Management
Our dedicated study team of talented professionals have many years of experience managing all aspects of a trial from study feasibility to close-out, with excellent training and relationships with the sites and Clients.
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 has worked with hundreds of investigators and sites. MEDIcept can also help with GLP animal studies to ensure early safety and efficacy.
MEDIcept’s 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 has experience in the 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), 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 is committed to your clinical trial while focusing on timelines, budgets and clinical outcomes, and collaborate with the sponsors to ensure 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 trials environment. And MEDIcept can provide both onsite and remote, as well as oversight of sponsor and investigator site files to ensure compliance with industry expectations and regulatory standards.
Vendor and System Management
MEDIcept formed strategic partnerships with trusted vendors such as laboratories, Imaging, Central Readers, and Centralized Equipment Providers to support your clinical trials. We also offer a full clinical system ecosystem for EDC, eTMF, CTMS, ePRO, IxRS, eConsent, Safety monitoring and management.
Data Management & Statistics
MEDIcept efficiently develops the appropriate Case Report Forms, establishes and validates electronic data capture systems, manages the data from development, data cleaning and database lock, and ensures integration with other systems such as laboratories, Imaging, Central Readers, ePRO, IxRS to support your clinical trials.
MEDIcept has experience in complex study development and statistical methodologies, and our SAS programmers can support all your study needs for different products, both pre- and post-market studies/registries.
MEDIcept can support your safety needs whether creating the Safety management plans and processes, defining the study-specific Adverse Events according to the regulatory guidelines for submission and reportability, or assembling safety committees such as study-specific Data Safety Monitoring Boards (DSMBs) or Clinical Event Committees (CECs). We review and discuss adverse event (AE) listings and report and follow-up with investigators on serious adverse events (SAE).
Vendor/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, provide support during the process, and, if necessary, provide oversight for corrective actions.
Are you making devices under EU MDR 2017/745, which became effective in 2021? Are you ready to start the Post-market Follow-Up Studies? We can help!
Our experts can support your clinical evaluation reports (CERs), with a successful track record for all CERs and all Class devices submitted under Medical Device Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), thus far.
We write clinical study protocols and reports. We can assist with training and marketing materials development, as well as conference and manuscript writing.
Clinical Regulatory Strategy and Submissions
Clinical regulatory strategy is determined in collaboration with a client’s regulatory strategy and country-specific timelines for the most efficient product market strategy. MEDIcept’s clinical team develops US and OUS strategies and communications with regulatory authorities for medical device clinical trials, as well as in-country required submissions for product clearance and/or approval.
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.