Quality in clinical trials, use of ePRO and evaluation of pharmaceutical start-ups

On October 09, 2017 OCT held the 5th annual conference ‘Clinical Trials In And Outside Russia’ attended by representatives of pharmaceutical companies, experts from the Federal Service for Surveillance in Healthcare, Ministry of Healthcare and R&D establishments.

The first 30 guests of the conference received a gift: the ‘Guideline on Evaluation of Medicinal Products’ under the editorship of A.N. Mironov published by the Federal Service for Surveillance in Healthcare.

The conference was opened by a session on quality in clinical trials. Dmitry Goryachev, Head of ‘SCEEMP’ of the Federal Service for Surveillance in Healthcare, presented his paper on expert review of clinical study reports. OCT Clinical Operations Director Irina Petrova spoke about deviation management. OCT Medical Writer Vladimir Chistyakov shared special aspects of protocol writing which contribute to better quality of clinical trials. OCT Head of Quality Assurance Department Maria Zaytseva and Federal Scientific Clinical Center of Physical and Chemical Medicine Biostatistician Irina Bondareva also took part in the session. The speakers answered a number of interesting questions and comments that were raised by the participants.

At the end of the first part of the conference, the guests attended one of the parallel sessions. Data MATRIX have arranged a session on electronic diaries (ePRO) to share its experience of implementing an ePRO-based approach in clinical trials, together with pharma and CRO representatives. This part of the event also focused on translation and language validation of questionnaires.

Concurrently, venture biotech fund Primer Capital held its session ‘Pharmaceutical Start-Ups: Expert Evaluation’. At the beginning of this session, a number of investment documents were signed with MT-Medicals. The total amount of investment round was RUB 44 M. After that, invited speakers from the Ministry of Healthcare, Primer Capital, Skolkovo Foundation and Pharmstandard spoke about supporting tools for innovative developments with particular focus on project evaluation and analysis.

‘We always strive for our conferences to include the most relevant issues and the best practices we have learned and implemented over the past year. We are always keen to receive feedback from our guests whose participation helps us to make an interesting program for this Russia’s unique clinical research event. We are planning to hold yet another meeting with pharmaceutical companies to discuss clinical research budgeting till the end of this year,’ comments OCT President Dmitry Sharov. 

To visit the gallery of the event, follow the link.