WHAT WE DO
Waife & Associates, Inc. is a management consulting firm dedicated to improving the performance of clinical research. We are unique for the following key reasons:
- We know the biopharma clinical development process thoroughly, as practiced by companies large and small, new and established, manufacturers and service providers. You do not have to teach us your business.
- We apply senior industry experts to your problem – no “kids off the bus”.
- We are independent of all other vendors or services.
- We have been industry thought leaders in the application of process improvement principles and new information technologies.
- We develop pragmatic strategies which fit your specific company situation, based on over 20 years of experience over hundreds of clients. We know what works and what doesn’t work.
- We stay with you, and help you operationalize and implement new processes and technologies.
WHAT YOU CAN EXPECT
- We work within the context of your key business drivers, and understand their operational implications.
- We apply experience, method and judgement. Our methods have been developed at MIT and Japan and the CQofM; our direct experience in industry management, and our judgment based on our maturity, is what elevates our assistance to unique value.
- We will tell you frankly what we have found, and what is likely to work and not work – what we call “truth-telling”.
- We use an event-driven schedule which minimizes your time required and our cost to you.
WHAT WE DON’T DO
- We don’t tell you what you want to hear, unless it happens to match what we found in our work with you.
- We don’t try to sell you our parent company’s services or software -- we don’t have a parent company!
- We don’t “move in” to your offices and run up large fees just by living with you.
- We don’t hold weekly meetings, taking up your valuable staff time, just for the sake of having meetings.
- We don’t walk out after delivering high-level solutions and obvious platitudes.
AREAS OF EXPERTISE
Recent W&A assignments have focused on:
- Clinical Operations
- Vendor Oversight Management
- Clinical Data Management and Biostatistics
- Clinical Research Informatics
- Pharmacovigilance Operations
We prepare your organization to implement technologies such as:
- Electronic Data Capture
- Electronic Trial Master Files
- Clinical Trials Management Systems
- Safety Systems