1

Price

Because I work as an independent, I don’t have the overhead of a large organization and can charge less than someone with my skills and experience that works for a CRO.

2

Quality

I do all the work. Nothing is outsourced; nothing is given to another person.

3

Communication.

I understand the issues, problems and terms used by your people in regulatory affairs, compliance, QA, database support, statistics, programming and technical writing.

Because I understand a wide range of subjects a company can hire one person to accomplish a variety of tasks. This saves time and money. You interact with one person rather than two or three.

4

Efficiency

I am a one-person CRO. I can solve problems in all areas except manufacturing.

Because I understand a wide variety of subject areas; I recognize the impacts and relationships between areas. I know how all the pieces of a clinical trial and a submission fit together. For example, I can analyze the impact of trial design on database structure. I can evaluate the effect of alternative regulatory strategies on the statistical analysis of a trial. I can improve your processes to ensure any audit can be passed.

5

Training. With my help, you can do more work in-house

One of the best ways for a company to save money is to perform more work in house. I have developed over 23 classes on technical and regulatory topics and can train a company’s staff while solving problems.

6

Cost sensitive

I specialize in creating practical solutions that fit the time and budget constraints that exist at every company. I apply my technical skills and first-hand knowledge of FDA reviewers to create unique answers to troublesome problems.

7

Former FDA reviewer

I have worked both sides of the regulatory fence having both reviewed and created submissions. I understand how to produce a “reviewer friendly” submission. I know what is important to a reviewer and can help you allocate resources and solve (or avoid) problems that could slow down approval.