As a critical component of clinical research, Biostatistics help define, facilitate and analyze medical device trials. Having the right Biostatistics consulting team to support your medical device development can make or break the process, so it’s critical to work with a team that’s proven in its ability to provide you with the clinical support and evidence you need to satisfy regulatory requirements. If you’re in the midst of product development, here’s a look at what Biostatistics outsourcing typically looks like in clinical research, and why you may want to consider it to ensure successful outcomes for your device.
What is Biostatistics Outsourcing?
Performing Biostatistical Research is a complex and nuanced process that requires unbiased research and carefully crafted testing. The inherent complexity is why so many medical drug and device manufacturers turn to Biostatistics outsourcing to ensure their product is tested in a way that will generate unbiased results that accelerate the approval process.
When you outsource Biostatistical programs, you leave trial design and development, data management and reporting in the hands of an expert team. NAMSA’s team of Biostatistical Researchers, for example, are experts in medical device research and can develop trials that properly randomize patient test subjects, and define test criteria to ensure an unbiased process. Our Biostatistics team has successfully led hundreds of medical device tests that provide regulatory agencies with compelling evidence. There is little room for error when designing and managing medical device trials, which is what makes our Biostatistics consulting team highly trusted in the industry.
Benefits of Biostatistics Outsourcing and Consulting
Choosing the right Biostatistics Consulting Team matters. When you select the right team, the benefits are an indispensable component of the approval process — here are just a few of those benefits.
Cost-Effectiveness: Working with an expert team means working with people who have been through hundreds of device trials. They’ve seen what works and what doesn’t, so you can count on a streamlined process that doesn’t use up unnecessary resources.
Expertise and Experience: The right choice for biostatistics outsourcing is a team that has wide testing experience and proven results. When you’ve found that partner, you’ll understand why. With little room for error in clinical research, expertise is of the utmost importance.
Resource Optimization: Selecting a team that doesn’t have the right background or breadth of experience can often mean a lack of resources during the clinical trial period. Ultimately, having to source missing resources will create additional expenses and delayed timelines for your team. NAMSA has teams around the world with various therapeutic device experience, which gives our clients access to local networks that provide effective, cost-effective research.
What’s included during Biostatistics Outsourcing?
The Biostatistics Team is truly at the core of all clinical trials. More than simply analyzing trial outcomes, this team develops the protocol and design of the trial to ensure randomization and unbiased results. This team is responsible for defining trial scope and objectives, establishing clear communication channels, ensuring data security and monitoring quality control. Of course, creating clinical study reports and data interpretations come after trials and will help support your device’s path to approval.
All of this contributes to generating evidence that gives your medical device the best chance of regulatory approval. The following are components of NAMSA’s own biostatistics consulting services:
- Adaptive Study Design
- Clinical Study Design: Endpoint Selection, Sample Size Calculations & Power Analysis
- Data Analysis for Scientific Papers or Regulatory Submissions
- Data Monitoring Committee (DMC)/ Data Safety Monitoring Board (DSMB) Membership & Support
- Global Regulatory Authority Meetings & Conferences on Statistical Design & Data Analysis
- Medical Device Data Analysis & Statistical Reports
- Clinical Trial Protocols & Statistical Analysis Plans Preparation
- Randomization Scheduling
- Statistical Analysis Preparation: Programming & Validation for Dataset Creation, Tables, Figures & Listings
- Targeted Biostatistics Consulting
Serving as your Trusted Biostatistics Consulting Partner
When you need a team you can trust to bring your product to market through compelling evidence and accelerated timelines, NAMSA is ready to help. Our global network of Biostatisticians can develop custom-designed trials that support your product’s get-to-market timeline. Get in touch with our team today to achieve successful medical device development, or discover more about our clinical trial research consulting services.
Leah Davidson, MA, MBA, PCM
Leah has been with NAMSA since 2016 and currently serves as Senior Manager of Global Marketing Communications. She possesses nearly 25 years' experience within the medical device and healthcare technology industries and has worked in various marketing and communications capacities throughout her career. In her role at NAMSA, she is responsible for the development and implementation of brand strategies and marketing communications initiatives that help drive the organization's sales and organizational growth goals globally.