Press release -
CTC and ERT present an Early Drug Development Workshop in November
As an ERT Certified Site, CTC Clinical Trials Consultants together with ERT, now present an “Early Drug Development Workshop: An Efficient Cardiac Safety Strategy for Drug Development” on November 13th.
We are pleased to invite you to an exclusive half-day, user-oriented workshop, addressing early ECG evaluation in First-In-Human trials and its practical impact on your clinical development strategy.
The sessions will discuss precise and efficient approaches to ECG evaluation in early phase studies, Expert Precision QT, and the importance of accurate data collection. Precise QT assessment accelerates earlier go/no-go decisions on compounds, save costs, and speed up market access.
Borje Darpo, M.D., PhD, ERT’s Chief Scientific Officer, who has collaborated with the International Council on Harmonization (ICH) on the endorsement of early phase QT evaluation as an effective replacement for the traditional Thorough QTc study, will detail Early ECG evaluation as part of planned First-in-Human trials.
Prof. Folke Sjöberg from CTC, will offer insight on the practical rollout of EPQT.
Dr. Eva Bredberg, former Director and Head of Clinical Pharmacology at Vertex Pharmaceuticals, will offer an industry perspective on ECG evaluation in clinical pharmacology studies.
Agenda for November 13th:
| Time | Description |
| 10:00 am | Introductions |
| 10:15 am | Early ECG evaluation as part of planned First-in-Human trials – Dr. Borje Darpo, Chief Scientific Officer at ERT |
| 11:00 am | Coffee break |
| 11:15 am | Practical insight of EPQT at a phase I unit – Prof. Folke Sjöberg, Chief Medical Officer at CTC |
| 11:30 pm | Lunch/facility tour and real-life demo of EPQT data collection |
| 13:20 pm | An industry perspective on ECG evaluation in clinical phamacology studies - what is a sensible and efficient approach? – Dr. Eva Bredberg, Former Director and Head of Clinical Pharmacology at Vertex Pharmaceuticals. |
| 13:50 pm | Q&A session with expert panel |
| 14:15 pm | Closing remarks |
Location: CTC Clinical Trial Consultants AB, Dag Hammarskjölds väg 10B, Uppsala, Sweden
For registration please email reception@ctc-ab.se
Topics
- Medical research
CTC Clinical Trial Consultants AB is a full-service CRO with focus on clinical conduct. Our mission is to facilitate clinical and translational research by providing our customers with cost-effective advice, conduct and reporting of clinical trials. We have four different departments: Clinic, Clinical Operations, Pharmacovigilance and Biometrics, all supported by independent quality assurance management.
Our head office and Phase 1 units are located in Uppsala comprising 28 beds of which 12 are hospital beds in a first-in-human approved research unit whereas our two professional sites for multicenter studies (SMOs) are found in Uppsala and Linköping. We have our own subject database for recruitment of both healthy volunteers and special patient populations.
CTC was founded in 2011 and has successfully conducted over 200 industry sponsored clinical trials for start-up companies as well as for international pharmaceutical companies and CROs. Our track record includes first-in-human, food effect, drug interaction, bioequivalence, bioavaliability and biosimilar studies, new drug delivery systems, medical device, PET/MR, QT and Phase IIa studies.
