I am pleased to reach out to you through this November 2021 edition of Oviya MedSafe‘s newsletter (the 110th in the series since April 2012) in which I intend to speak about our recent achievements in providing Pharmacovigilance support for Clinical Trials.
Although Oviya MedSafe has had Clinical Trial Safety Management in our list of offerings ever since we began our journey, most of our deliveries were predominantly in the Post-Marketing Pharmacovigilance space. We did have opportunities to work on Patient Safety Narratives for Clinical Study Reports and in Safety Monitoring of Patient Support Programmes & Market Research Programmes, which I had written about in quite detail, in 2015 and 2016. Apart from these, most of our clinical trial safety tasks were performed as part of a wider scope of comprehensive pharmacovigilance consulting assignments. Interestingly, things have changed a lot in the past few years, with many new international clients signing up with us for a bundled provision of regulatory-compliant pharmacovigilance software database deployment with long-term contracts for Oviya MedSafe staff to process and manage their clinical trial Serious Adverse Events (SAEs). While COVID-19 and its associated clinical trials could have been one of the reasons for the global demand for such services to pick up, I believe the situation also helped the market realize the significance of having a committed Pharmacovigilance partner like Oviya MedSafe.
Having had the experience of working with both established pharmaceutical companies as well as promising biotech start-ups, Oviya MedSafe fully understands how Pharmacovigilance in each clinical trial has to be treated differently while remembering that the core similarities do not change. Right from protocol finalization along with the client, Oviya MedSafe team invests quite a lot of time in crafting the Safety Management Plan (SMP) to make sure that every role, responsibility and timeline pertaining to the trial’s SAE Management are clearly defined. Oviya MedSafe’s dedicated Medical Safety team comprising of physicians takes care of the causality assessment and other medical review aspects while the Pharmacovigilance Operations team ensures that the SAEs are processed methodically in the system and the independent Quality Assurance team maintains thorough oversight of the entire process. Oviya MedSafe’s domain strength in regulatory compliance, technical prowess in global SAE submission procedures, structured Quality Management System, documented conventions of various case scenarios, and direct oversight of senior management have made us a trustworthy SAE Management partner for all types of clinical trial sponsors from different parts of the world. In fact, quite a few Contract Research Organizations (CROs) which run clinical trials on behalf of their sponsors have completely entrusted us with the Pharmacovigilance part with the approval of their sponsors, which I see as a phenomenal credential for Oviya MedSafe.
I was glad to have a chance to utilize our expertise in this subject for delivering a short talk on “Causality Assessment in Clinical Trials” to a group of Ethics Committee Members at the workshop titled “Good Clinical Practice and Regulatory Updates in Clinical Trials” organized by the Indian Society for Clinical Research (ISCR) at Coimbatore on 20th Nov 2021. I was happy to speak at a ‘real’ (non-virtual) event after almost 2 years and it was so heartening to meet colleagues face-to-face. As a Pharmacovigilance professional, I think there is always scope for improving dialogue among all stakeholders, especially in the clinical trial scenario where clear documentation, which is a function of clear understanding, is the key. I was also fortunate to be invited to give a lecture on “Role of Healthcare Professionals in Pharmacovigilance” at the 19th Skill Development Programme on Pharmacovigilance for Medical Products, organized by the Indian Pharmacopoeia Commission, Ghaziabad during the month.
I wish to conclude with something special: the recording of a webinar I organized on 23-Nov-2021 in my honorary capacity as the Chairman of the Indian Medical Association Headquarters Standing Committee for Pharmacovigilance. Moderated by Dr Pooja Sharma, the webinar titled “Drug Safety in Pregnancy & Lactation” had Dr Meenakshi Dua, Dr Sreelaxmi Kodandapani and Dr Nipun Patil as the expert panelists. Please click on https://youtu.be/a4j7Zf302q4 to watch it. Feedback is welcome.
I look forward to meeting you soon through our December 2021 newsletter.
Wishing you Merry Christmas and a Happy New Year 2022 in advance,
With thanks & regards,
Dr J Vijay Venkatraman
MBBS, F. Diab., MBA, FPIPA (UK)
Managing Director & CEO,
Oviya MedSafe Pvt Ltd,
Oviya MedSafe UK Ltd,