We provide consulting services to pharmaceutical and biotechnology companies for clinical development of treatments mainly in the areas of rheumatology and autoimmune diseases.
The pharmaceutical industry faces increasing challenges.
Competition, regulatory requirements, and costs have increased, while the rate of new products coming to market has decreased.
Problems in clinical development include:
Choosing the wrong initial indication; study design flaws; unnecessarily stringent study populations; inappropriate study site selection; and ignoring inherent problems in trials, which can be expensive and disastrous.
Circling back to fix problems will result in not only greater expense, but protracted timelines. Companies also find themselves searching the world to recruit sufficient patients to complete their trials.
We bring solutions:
Developing overall strategies at the outset with the end-goal in mind; thorough review and selection of the optimal indications; formulation of clinical development plans; optimizing clinical trial design; and focusing on what will be needed to accomplish the goals and timelines for the studies and overall program.
Startup biopharma companies; larger pharmaceutical companies that need specific advice in the autoimmune space; and CROs with programs in the autoimmune space.
Our business model:
We generate revenue through consulting fees. We work remotely and do not consult at the company location apart from meetings. We provide consulting work under contract on behalf of our company, not as an employee of our clients. We have usually traveled in person to meetings and to provide training. (This will depend on the status of the COVID-19 pandemic).
Why work with us:
We have consulted for startup companies to select indications, design and complete trials that resulted in successful licensing and acquisition deals. We have helped pharmaceutical companies: complete large multinational trials; provided chief medical officer services for early-stage companies; and provided consulting and oversight in the autoimmune space for CROs. We have advised and trained physician and clinical operation teams on outcome measures and prepared them to present at investigator meetings and to large pharmaceutical clients.
For more information, and to let us know what you are working to achieve.