AlvaMed was able to support the company’s aggressive timelines to gain study approval and operationally prepare the company to open enrollment in advance of product availability.
Operating and managing clinical studies is a complex endeavor often with multiple stakeholders involved in the process. The AlvaMed team has the skillset and the depth of clinical experience in successfully launching, operating and managing clinical studies, to provide the most efficient CRO services to you.
Study Protocol development, biostatistics, CRF development, database design and build.
Site qualification, contracting, budgets, IRB/EC submissions, site initiation and preparedness.
Site management, enrollment, project management, trial master file and regulatory management.
Site Level Study Monitoring and Oversight.
Identification and management of DSMBs, CECs, and oversight of all study related safety activities.
AlvaMed was able to support the company’s aggressive timelines to gain study approval and operationally prepare the company to open enrollment in advance of product availability.
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
I just wanted to say thanks again for all of the hard (and high quality) work that you’ve done to support BFKW but most recently, getting the BFKW India trial up and running. It seems like it’s been “crunch time” for a while now but the team has pulled it off with the recent formal opening of enrollment.
BFKW, LLC
Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.
MedTech Client
No, we can design services that are custom tailored to your needs. We offer a wide menu of services and provide the guidance needed to most efficiently meet your needs and maintain study compliance.
Yes. Please see our list of therapeutic areas and other CRO/clinical affairs services available here.
We minimize costs using fewer layers of management, opting to use a deeply experienced lead manager as the key contact on each project.
Book some time with Kerry to find out more about our comprehensive services and to hear more about our team of clinical research professionals, dedicated to your company’s success.
