Medical Device CRO Services

Clinical Investigation Plan, Study Design, and Protocol Development

Clean, valid data is essential for supporting a premarket submission or post-market compliance.  When a clinical study goes awry due to enrollment or data problems, it can often be traced back to poor study design. Carefully crafted clinical trial designs are vital for ensuring that study protocol supports collecting data in the right way. Spending time up-front on study design and clearly defining endpoints and patient population paves the way to gather the scientific evidence you will need to prove the safety and efficacy of your device.

NAMSA is the largest clinical research organization dedicated to medical devices and IVDs. Every year we conduct hundreds of medical device clinical projects in a variety of therapeutic areas. We have particularly deep expertise in cardiovascular, orthopedics, infectious disease, and wound care.

Clinical Trial Management

NAMSA is the world’s leading clinical research organization focused on medical device and IVD technology. We have managed hundreds of trials and understand how to keep trials on time, on budget, and – most importantly – protect the validity of your study data. Our clinical trial research teams are committed to meticulous planning and communication to manage costs and accelerate timelines to move your device to the commercialization phase as efficiently as possible. Each study undergoes regularly scheduled reviews during which our project managers and clinical study managers scrutinize data quality, budget, and timelines while addressing potential risks or roadblocks. NAMSA can assist with some of all aspects of your study.

Clinical Trial Data Management

Bringing a new medical device or In Vitro Diagnostic (IVD) to market is a huge investment and much of the expense comes from gathering clinical data. The success of your regulatory submission is highly dependent on the quality and accuracy of your trial data. NAMSA can help ensure that your clinical investigations meet ISO 14155, 21 CFR Part 11, and other applicable regulations for data completeness, accuracy, and security.

NAMSA offers a full range of clinical research consulting solutions for comprehensive data management and support, delivered by our experienced clinical data managers and clinical database developers. These team members, cross-trained and integrated with our clinical study management and biostatistics teams, provide services ranging from design and database development to data cleaning and monitoring support.

Clinical Trial Biostatistics

With an average of 20 years of experience, each clinical research consulting team member is 100% medical device-focused and understands the nuances and requirements of medical device statistics and data and how to deliver a custom-designed program that maximizes biostatistics efforts and outcomes. Some of NAMSA’s biostatistics and statistical programming solutions include:

• Adaptive study design
• Clinical study design: endpoint selection, sample size calculations and power analysis
• Data analysis for scientific papers or regulatory submissions
• Data Monitoring Committee (DMC) and Data Safety Monitoring Board (DSMB) membership and support
• Global regulatory authority meetings and conferences on statistical design and data analysis
• Medical device data analysis and statistical reports
• Clinical trial protocols and statistical analysis plans preparation
• Randomization scheduling
• Statistical analysis preparation: programming and validation for dataset creation, tables, figures & listings
• Targeted biostatistics consulting

Pivotal Clinical Trials

NAMSA’s clinical research team provides customized clinical study design and protocol development that balances the interests of multiple stakeholders. This is achieved by collaborating with our internal regulatory, reimbursement and statistical teams.

Our clinical trial research consulting teams are expert at advising on the necessity, implications and practicality of clinical study design factors, unlocking the full potential of trial protocol and ensuring that all stakeholder perspectives are properly addressed. Each study undergoes regularly scheduled reviews in which NAMSA’s project management team and clinical study managers scrutinize key factors such as quality, budget and timelines while also proactively addressing potential risks or roadblocks.

NAMSA is ISO 9001:2015 certified and adheres to applicable global regulations and standards for patient protection and clinical data integrity. We have well-established SOPs for the planning, initiation and conduct of studies. Our clinical trial research teams are committed to meticulous planning and communication to manage costs and accelerate timelines to move your device to the commercialization phase as efficiently as possible.

Options we offer to support your Pivotal Clinical Trial are:

• Site Management and Monitoring inclusive of Risked Based Monitoring
• Data Management
• EDC Database Development
• Study Management
• Electronic Trial Master File (eTMF) Management
• Project Management
• Local Submissions and Trial Registration
• Randomization
• Synopsis and Protocol Development
• FDA Pre-submission Support
• IDE submission Support

Post Market Studies

Medical device sponsors are intimately aware that regulatory approval is one step on a long term journey to create a meaningful business while supporting additional safety and efficacy monitoring.  Post Market studies can help to enhance a market approval with clinical evidence to back a product’s claims and reimbursement objectives. Further, new and novel devices often require a period of follow up as defined in MDR and IVDR through the PMCF and PMFP plans. Navigating these requirements and the business needs, can create a tricky situation for most sponsors. To help, NAMSA offers a broad array of clinical evidence and post-market study support services to assist manufacturers to monitor, justify, bolster and differentiate product claims to clinicians, patients and payers.

NAMSA supports each client based on their unique clinical claims and objectives, taking into account desired timelines and budgets. Together with our global Regulatory consulting team, we can devise a plan to meet your regulatory as well as your business needs for post market studies.  Our most requested support options include:

• PMPF/PMCF Gap Assessment and Strategy
• FDA Condition of Approval Studies
• Literature-Based Meta-Analysis
• Post-Market Patient Registry Study
• Randomized-Controlled, Multi-Center Clinical Trials
• High Quality Clinical Surveys

Clinical Study Reports

Clinical Study Reports (CSRs) are comprehensive documents that summarize the methods, results, and conclusions of a clinical trial. CSRs are essential for regulatory submissions, publications, and marketing activities. They provide the evidence to demonstrate the safety and effectiveness of a medical device in a specific patient population and clinical setting.

A well-written clinical trial CSR can help speed up the approval process and the market acceptance of a medical device. A poorly written medical device clinical study report can lead to delays, rejections, or unfavorable reviews. Therefore, qualified medical writers who understand the regulatory requirements, international standards, and the industry best practices, which will help raise the bar of your report development.

Imaging Core Lab Services

With technology at its crux and a dedicated team of world-renowned physicians at the helm, NAMSA offers the highest quality Imaging Core Laboratory (ICL) services in the CRO industry. Our expert imaging reviewers ensure quality and accuracy of image interpretation and analyses, and our highly efficient processes leave little for the Sponsors to manage.

Benefits of NAMSA’s Imaging Core Laboratory include:

• End-to-end service from image transfer and database set-up to site training on image acquisition and transfer
• Study protocol review for imaging endpoints
• Seamless integration and leverage of systems across NAMSA
• Transparency at every step and real-time client access to data
• Industry-best image reviews and turnaround times

With zero FDA audit findings and ISO 9001:2015 accreditation our imaging core laboratory has reviewed over 12,000 images and supporting over 40 PMA approvals for the FDA. Here are some examples of the types of image expertise our team can support:

• Computed Tomography (CT) Scans
• Magnetic Resonance Imaging (MRI)
• Angiography
• Intravascular Imaging System (IVUS)
• Optical Coherence Tomography (OCT)
• X-ray
• Ultrasound
• Echocardiogram
• And more

Medical Writing Services

NAMSA provides a wide range of specialized clinical and regulatory medical writing, manuscript submission, and evidence communication services. Our world-class team of medical writers is expert at identifying, organizing, interpreting, and presenting clinical data accurately and professionally for submission to various regulatory bodies.
Working in collaboration with our US and EU regulatory teams, we have extensive experience preparing:

• Clinical Evaluation Reports and Plans (CER and CEP)
• Performance Evaluation Reports and Plans (PER and PEP)
• Clinical Literature Reviews
• Periodic Safety Update Reports (PSUR)
• Post Market Surveillance Reports (PMSR)
• Summaries of Safety and Clinical Performance (SSCP)
• Clinical Study Protocols
• Clinical Study Reports (CSR)

Clinical Outsourcing

The clinical stage of your product development life cycle is arguably the most important on your road to regulatory approval. Even small mistakes early in your clinical research have severe regulatory consequences as endpoints are not met. These mistakes can delay your time to market and cost your company millions. When you work with NAMSA, you are making an investment in derisking your path to premarket approval. With NAMSA as your clinical trials outsourcing partner, you are getting access to the deepest team of clinical subject matter experts, all of whom focus entirely on medical devices and IVDs.