Navitas Life Sciences is committed to transforming healthcare. In 2020, that has included identifying solutions for COVID-19, while effectively dealing with multiple layers of complexity. We have been working with industry experts, global pharma, and various organizations from across the world supporting clinical trials to help bring better treatment solutions for people affected by COVID-19.

Accelerating Change

Since the onset of the pandemic, we have been accelerating change; leveraging our artificial intelligence and machine learning technologies, deep domain expertise, and vast experience to circumvent challenges and to mitigate risk.

Navitas Life Sciences has invested in digital tools, like OneClinical^®, for optimizing clinical trial efficiency, exploring their use in patient recruitment and in the management of trials. Such tools have helped in transforming clinical trials by leveraging near real time data insights that have aided enhanced clinical trial monitoring, assisted in clinical trial design, patient recruitment and ensured better patient retention.

We have been running clinical trials for over 30 years, growing in strength over time by investing in the right technology, and our ability to adapt to changing needs. Our DNA values of a high-performance mindset and ensuring customer delight has helped us withstand unprecedented changes and challenges.

Translating Norms into Reforms

During the early stages of the pandemic, we exhibited agility in adopting virtual clinical trials, however, it was a holistic change. The process of change not only utilized our insight driven technology for running trials, but it also engaged the entire company, with virtual meetings and training offered.

There was a need to articulate our focus of supporting efficient clinical trials, while adapting to the changes, as a team. By rewiring ourselves to incorporate digital solutions, wherever possible, we have been able to augment our capabilities and support much needed clinical trials for the treatment of COVID-19.

Here are some of the clinical trials we have supported for potential therapy for COVID-19:

1) Safety and efficacy of marketed drugs

A multinational mid-sized pharma company based in India needed an end-to-end clinical trials partner for a randomized, open label clinical trial to evaluate safety and efficacy of multiple marketed drugs in the acute treatment of COVID-19 patients. The study needed to be completed within 8 months, on 160+ randomized patients, from 10 sites across India.

2) Safety and Efficacy of Adjunctive Therapy

A mid-sized multinational pharmaceutical company needed an efficiently run clinical trial to evaluate the safety and efficacy of an adjunctive therapy to standard care against the use of standard care alone, in the acute treatment of moderate to severe COVID-19 patients. An initial safety study for 40 patients was to be conducted and, based on the results, the study would be extended.

3) Safety, Tolerability and Efficacy of Intramuscular Drug

A global pharma needed expeditious and efficient conduct of a Phase I trial to evaluate the safety and tolerability of an anti-parasitic drug in the treatment of COVID-19. The drug, delivered as an intramuscular depot, was found to be efficacious against SARS-CoV-2 in preclinical studies. As this is a novel route of administration, the company needed to apply for a New Drug Application.

The safety and tolerability study on healthy volunteers was initiated successfully and efficiently. The synopsis to proposal to protocol finalization were completed within 2 weeks. Expert insights were leveraged to develop documentation for submission to health authorities. Our team enabled a quick turnaround with milestones completed ahead of time.

4) Safety and Efficacy of Drug for acute treatment

A multinational pharma company needed a partner to conduct a safety and efficacy trial in the acute treatment of 60+ moderate to severe COVID-19 patients.

The trial was conducted across 10+ sites, and it was completed successfully, adhering to all milestones and to the satisfaction of the sponsor.

5) Safety and Efficacy of drug for moderate to severe COVID-19

A multinational pharma company needed a partner to conduct a safety and efficacy trial across global sites, requiring over 750 study participants. The trial is running successfully, with more than 300 participants recruited.

6) Safety and Efficacy of alternate treatment for COVID-19

A multi-center study to identify the effectiveness of alternative therapy in the treatment of COVID-19, to be conducted on over 80 study participants.

Technology has helped us carry out efficient virtual clinical trials, by improving our trials at various stages. We now have better and faster insights about study participants, enabling improved patient recruitment and management, with insight driven decisions taken during the course of the study. Generating these insights and utilizing them effectively has been a major inflection point in our drive to utilize science for better health.