An Early Phase Study Design and Clinical Development Consultancy With a Difference
Our consultants work with you to design early phase studies and development programs that manage risk are cost and time efficient while being effective for your development needs. We strive to bring promising new therapies to patients faster, resulting in cost and time savings for your company and more importantly, impacting patients lives.
Our people bring decades of work experience to your clinical development programs thus adding significant value to your program overall
Some areas in which our team specializes include:Talk to us Today!
SOUND REGULATORY INSIGHTS
Our team has the knowledge to support your needs throughout the product lifecycle. This includes defining the regulatory development strategy, producing clinical trial and marketing authorisation submissions etc.
TRIAL PLANNING & DESIGN
Our experienced team not only helps you create your strategic clinical development plan, but also provides tactical support to develop the clinical trial design; determine sample size calculations; write, edit or review protocols and so on.
GATED TARGET PLANNING
Our team will guide you in planning targets and develop strategies to help meet them.
We use an out-of-the-box thinking approach to come up with creative solutions that will help you meet your development goals faster.
Each project is unique and has its own set of challenges and complexities be it related to design or regulatory strategy. Our team has ‘been there, done that’ and has the ability to identify possible pitfalls and plan for them proactively resulting in time and cost benefits for you.
IMPLEMENTATION & LOCATION ADVICE
Having experience with recruiting for many studies across therapeutic areas we know which geographical locations may be better for recruitment than others. Choosing the right locations for your studies can be the deciding factor between success & failure.
WRITING, PUBLISHING & SUBMISSIONS
With years of successful clinical research submissions to regulatory agencies, our team of consultants has a specialized skill of clear and precise writing. We are able to assist with protocol writing, study reports, IB and other essential documents.