Medical Device and IVD Clinical Trial Management

Let NAMSA Assist in Managing Your Clinical Study

A well-managed clinical trial maintains a balance between patient safety, trial efficiency and the desire to enhance patient treatment options. With so many moving parts, any errors in study design, data, management or execution can have costly consequences.

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 and patient safety. 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 including:

• Planning and start-up – Setting trial objectives, overall strategy and clinical trial protocol development
• Regulatory and IRB/EC submissions – Completing your submission for your trial based on the local country requirements, ethics committees and internal review boards (IRB)
• Trial registrations – Registering your trial with the appropriate platforms to maximize recruitment
• Site management –Determining which sites are appropriate for your device and coordinating with them throughout the qualificiation, initiation, start up, enrollment, follow up, and close out
• Data integrity – Developing and setting up your EDC system plus ongoing database management, data cleaning, validation, review, and analysis
• Budget management – Ensuring that your trial stays on budget and coordinate all finances and tracking as needed
• Regulatory – Meeting all applicable US FDA and EU MDR/IVDR regulations, and adheres to international standards incuding ISO 14155
• Key Opinion Leaders (KOL) – Leveraging NAMSA connections with KOL to inform the design and execution of your study

Highly-Refined Four Team Approach

NAMSA trial management teams take a four team approach to managing the full scope of your clinical team with our experienced experts:

1. Clinical Study Manager – The CSM leads study execution and is the primary contact across the NAMSA study team and with the Sponsor team. Our team of experienced CSM also cover protocol compliance, development and compliance to study plans (e.g., monitoring, training, plans), development of training materials, tools, and study reports, and overall site management from site qualification through activation, enrollment, and close-out.
2. Project Manager – Our PMs work hand-in-hand with the CSM and are responsible for timeline, cost, and quality of the overall project milestones. The Project Manager initiates and manages project plans (e.g., communication, escalation, roles and responsibilities), conducts internal and sponsor meetings, ensures quality, and manages resources, timelines, and the project budget.
3. Clinical Research Associate – Our CRAs manage the day-to-day monitoring and interactions with each of the sites. Excelling site partnerships, our expert CRA’s keep sites moving forward targeting your enrollment targets. Responsible for training, IRB and/or EC assistance, addressing entry criteria and protocol questions, monitoring, and site close-out. The CRA assists the CSM and PM with implementing the project to the clinical monitoring plan, prepares regulatory binder logs, schedules/reviews monitoring reports, ensures consistency across sites, and manages all aspects of site start-up and site management.
4. Clinical Trial Associate – NAMSA Clinical Trial Associates are the backbone of support for the compliance of the Trial Master File. They ensure all documents, trainings, and materials are captured in our electronic Trial Master File (eTMF) and track down any missing documentation. The CTA is responsible for maintaining the accuracy and completeness of the Trial Master File (eTMF).

Stringent Procedures and Deep Expertise in Medical Devices

NAMSA is ISO 9001 certified and has well-established procedures for the planning, initiation and conduct of studies. We adhere to FDA, EU and global regulations and standards for patient protection and clinical data integrity. Each study undergoes regularly scheduled reviews in which our Project Management Team and Clinical Study Managers scrutinize key factors such as quality, budget and timelines while also proactively addressing potential risks or roadblocks. Because Key Performance Indicators are an important part of any clinical trial, our team reports these metrics on a regular basis to our clients:

• Number of CAPAs created and resolved
• Number of AEs/SAEs per site/country/study
• Number of database queries created and resolved
• Number of days to data entry per site/study
• Number of monitoring visits completed and reported per CMP
• Number of planned and unplanned SOP deviations
• Number of audits completed at site and study levels
• Number of audits with major findings
• Number of major findings resolved and time to resolution
• Patient population diversity

Supporting Your Regulatory and Reimbursement Goals

NAMSA is skilled at securing data that is most likely to support regulatory and reimbursement goals. We have an experienced team of FDA and EU regulatory experts on staff, all of whom work closely with our clinical team to ensure your study meets regulatory submission requirements. We are ready to tackle all field clinical needs that your study may require. By entrusting the management of your clinical study operations to us, you can be confident that your research objectives are met on time and within your budget.