Powering intelligent Clinical Trials from Russia – Insights from our Head of Russian Operations, Natalya Volkova

Navitas Life Sciences rapidly mobilized its digital resources during the COVID-19 pandemic to ensure the smooth transition into remote work. Thus, despite mobility restrictions we could safeguard the health of employees and patients through the pandemic. During this time, across the globe, we witnessed a significant and historic shift towards remote practices.

The shift towards virtual clinical trials has vaulted us nearly 5 years ahead, with digital tools used to collect patient data, an analytics platform to gather near real-time information, tele-medicine to check patient progress and side effects, and more. Navitas Life Sciences supports ongoing clinical trials and new studies by leveraging strengths from our global offices and workforce.

Natalya Volkova, PhD, MD, MBA joined Navitas Life Sciences over 9 years ago. She is a medical doctor with a PhD in General Medicine, and a Masters’ Degree in Economics and Business Administration. Natalya is well versed in clinical trials, having joined the industry as an investigator in 2002. Today she is the Head of Russian Operations of Navitas Life Sciences working from our office in Moscow, Russia.

What are your roles and responsibilities, and what do you think are your unique traits that enhance these aspects?

Since 2002 my roles in the life sciences industry have been varied and have covered the following: Investigator, Clinical Trial Assistant, Clinical Trial Associate, Qualified Person for Pharmacovigilance (QPPV), local and international Project Manager, Head of Representative Office/Head of Clinical Operations for Russia, and CIS.

In my opinion, my strengths are my medical knowledge and practice, working in various positions in the field of clinical research, working experience with clinical trials professionals from different countries, and my continuous improvement of skills

What are the services and solutions provided by the Navitas Life Sciences office in Russia?

We are a close-knit team of professionals with wide experience in various fields of medicine, clinical research phases. We are supported by the wider Navitas Life Sciences family with strong expertise in clinical, regulatory and pharmacovigilance. We fully understand and follow the high standards of organizing and conducting local and international clinical trials, protecting the rights and well-being of patients, and fulfilling the high expectations of our clients.

How are clinical trials in Russia supporting global organizations?

In Russia, we have a huge territory and population. Our regulatory procedures are harmonized with international standards. In addition, our investigators are highly educated, with the majority of our CRO staff being trained medical doctors. This enables us to support short ‘regulatory and clinical trials conduct’ timelines, accelerating our clients’ product to market.

Why are Russian clinical trials strategically important in the global scenario?

The existence of developed regulatory procedures harmonized with recognized international regulatory practices, the short timeline of obtaining clinical trial approvals, competitively fast patient recruitment, and the quality of clinical trial conduct make Russia strategically important in the global clinical trials scenario.

What are the key therapeutic areas covered in Russia for Clinical studies and what are the advantages provided by our Russian office in the Clinical trial market?

The key therapeutic areas covered in Russia for clinical trials are related to endocrinology, pulmonology, cardiology, oncology, dermatology. But Russian sites and investigators have differentiated experience and strong expertise in different therapeutic areas to bring benefits and new treatment options to participating patients.

Can you share some recent success stories?

We always work to satisfy the expectations of our clients in order to reduce time to market and protect the wellbeing of our patients. A significant success story that I would like to highlight is our contribution towards a COVID-19 clinical trial that was conducted recently.

As soon as we were notified about our urgent need to join the global Navitas Life Sciences team to manage COVID-19 treatment trial in UAE and Bulgaria, our team in Russia rapidly mobilized resources to join the project. By leveraging our up-to-date technologies, fast learning, experience, medical and project management background, our Russian team implemented project management and regulatory support for successful management of the project that was conducted outside of Russia. The project scope was completed within target timelines.

How did Navitas Life Sciences get it right in the midst of the global pandemic?

Navitas Life Sciences has a structured approach to ensuring that we have the right capabilities to support efficient clinical trials. We have invested in digital solutions and advanced technology that provided remote support to sites, enabled the implementation of remote practices throughout the organization, as well as aided the virtual monitoring of clinical trials.

What are the lessons that you will take forward from the last year?

On the clinical trial front, the rapid migration and adoption of digital solutions has helped address and strengthen our capabilities in line with current expectations of efficiency. We constantly invest in developing resilient solutions that help to mitigate risk associated with unprecedented changes. It also highlighted to us that if you love your work – you always will move in the right direction.

What would be your advice to young minds entering the clinical trials industry?

I encourage people to love what they do, and to be sure that that their work makes them happy. Nobody should hesitate to learn and to be ready for very hard work.

In 2021, the cost of bringing prescription drugs to the market is estimated to be $985.3 million, while it is estimated to be nearly 3 billion for medications which are developed using specialized therapy, like immunomodulating agents. The rising costs of drug development affects patients who need to pay more for drugs, as well as the pharmaceutical industry. We have the right experience, expertise, and technology to support efficient clinical trials and help lower cost and time.

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