What, Why, Where, When and How to hold your first First-In-Human trial? …and other important clinical trial answers
November 15, 2018
Thursday, November 15, 2018 2:00 pm - 5:30 pm
You’ve answered some basic science questions about a drug’s safety and are ready to move to the clinic… There is a lot to consider including study design, cost/incentives, speed, quality, the participant pool, communication/language, partners, your market, standard of medical care, data integrity and more! To answer these questions, we've assembled a group of experts to help you prepare before you take the next steps.
This clinical trial workshop will bring together experts in the field from Johnson & Johnson, CROs and agencies to discuss advantages, challenges and experiences in running trials around the globe
Topics will include:
Preparing for your FIH, Phase 1B trials
- The questions you should be asking – what, why, where, when and how?
- High level considerations when planning clinical trials
- The importance of proactive planning and the right partner
- Partner/vendor/country selection
- Regulatory environment
- Study populations and design
- Safety considerations
Study location considerations
- What are the real differences/advantages for a young company that has limited resources going to other locations for clinical trials?
- Standard of medical care and data integrity in THAT country
Timelines & costs: If you are thinking about your clinical trials, attend this session to gain key insights into the details of executing your first trials. There will be plenty of time for group Q & A and meeting 1-on-1 with providers.
PAREXEL Speaker: S.Eralp “Al” Bellibas | Vice President, Medical Sciences/Clinical Pharmacology, Parexel Early Phase (BIO)