EXPERIENCE
Often the therapeutic area is less important than understanding the perils of transitioning to regulated clinical studies and the challenges of successfully managing clinical studies, however, as would be expected, our consultants and leadership have vast experience in almost all therapeutic areas.
TYPES OF ORGANIZATIONS
We have consulted for a variety of organizations that are involved in clinical development, including pre-funded early-stage companies to public companies with a deep pipeline of products in research to academic organizations developing their own products to be licensed to companies for commercialization.
PHASES OF DEVELOPMENT
Our clients have been engaged in all phases of development, from pre-clinical research studies to patient centric registries, although most have been early phase I and II studies where we assist in clinical operations and the overall management of clinical studies.
PRODUCTS
We have experience in managing programs for medical devices, small molecule drugs, biologicals, and cell and gene therapies. Most recently, our clients have been developing immunotherapies for oncology.