Clinical Study Reporting is often a daunting and time-consuming endeavor, whether it be updating an IRB or Ethics Committee, or for regulatory agency filings. AlvaMed works either as a collaborative partner or entirely independently to provide timely, customized, and high-quality clinical reports.
We will carefully assess your clinical study data and compare that to the requirements of the local IRB/EC or regulatory body requirements. As needed, we can also engage with our Biostatisticians to provide summary level data or full analyses to ensure all relevant areas required are covered in your report.
Our reports will check all the boxes to put your study in the best position for successful reporting to local and federal bodies.
We will work closely with your internal team to ensure that the final document submitted provides the relevant details for your study and aligns with the corporate and strategic goals for your product and company.
As needed, we will provide additional support with the regulators. Our many years of experience with these types of submissions at both the local and federal level, gives us a unique perspective on how to ensure smooth interactions.
AlvaMed effectively conducted the IDE study, performed study data cleaning, closure, issued the final study report after meeting the client’s enrollment needs, and received De Novo clearance for the client’s device based on final IDE study report data.
The AlvaMed Team played a pivotal role in our early success and the achievement of our key milestone – our First-In-Human clinical experience. Their unwavering support and expertise were instrumental in navigating challenges and driving us forward. We highly recommend AlvaMed as a dedicated and invaluable partner committed to turning visions into reality.
CEO, Co-Founder, Eclipse Regenesis, Inc
Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.
MedTech Client
It’s 75 degrees and sunny and I’m on my front porch thinking back on all the great work that has been done over the last six months. I feel quite fortunate to have found such a great team to work with in AlvaMed. We seriously could not have done this without you. This has been one of the most challenging projects I have ever been involved with. Looking back, I feel AlvaMed was the perfect choice.
Pfizer
Timing of reports is based on a number of factors including study complexity, intricacy and volume of the data, and the potential need for subsequent statistical analysis. Our aim is to map these events well in advance so that the timing can be addressed up-front, leading to better execution on the back end.
Once submitted, most reports need no further interaction with an agency. Although additional interactions with an agency may occur with complex studies, AlvaMed’s years of experience with these types of interactions help our clients successfully navigate these more complex scenarios.
The most common challenges are the failure to follow the investigational plan, inadequate and inaccurate records, inadequate device accountability and inadequate monitoring. In addition to providing clinical study reports, AlvaMed can assist you in other areas that represent these challenges with our CRO and Clinical Operations services.
Marc and his team of clinical research experts have deep knowledge of the needs of IRBs and Ethics Committees, as well as extensive experience with reporting to the regulatory bodies which govern us both domestically and internationally.
