Navitas Life Sciences has been successfully supporting the development of therapeutic treatment towards COVID-19 through our multifaceted end to end solution approach from design to execution. . In the face of the global crisis, we have gained extensive experience, access to network of infectious diseases sites, decentralized outreach and indepth understanding of operational nuances
Navitas Life Sciences’ Vast Clinical Trial Experience
Navitas Life Sciences’ accelerated pace of technology incorporation into clinical trials aided in strategic shift towards decentralized trials during the start of the COVID-19 pandemic. Our experience and expertise supported clinical trials throughout the pandemic, including for COVID-19, beating the odds to find better treatments.
Right from phase II to phase IV, we support your organization from design, startup to closure, and beyond, with ourmedical expertise, regulatory insights and quality approach. Our services are backed by technology & analytics that can be tailored to specifically meet unique challenges to gain faster access to the market.
36+ Immunology / Infectiology and Vaccines Trials, including Covid-19
Efficient COVID-19 Clinical Trials to Support Treatment and Care During the Pandemic
Navitas Life Sciences has always been committed to transforming healthcare, and it continued during the pandemic. There were considerable innovative strides that were taken at the start of the pandemic, with the use of technology and digital tools to support hybrid trials.
Here are some of the COVID-19 clinical trials that were conducted to understand if certain drug products can effectively treat patients with symptoms of COVID-19 and to bring such drugs to the market quickly.
1) Safety and Tolerability of Repurposed Drug:
A South Korean Pharmaceutical company and an Indian pharmaceutical company, needed expeditious and efficient conduct of a Phase I trial to evaluate the safety and tolerability of the anti-parasitic drug Niclosamide in the treatment of COVID-19. The drug, delivered as an intramuscular depot, was found to be efficacious against SARSCoV-2 in preclinical studies. As this was a novel route of administration, the company needed to apply for a New Drug Application.
High Priority Phase 1 Double Blind Safety, Tolerability and Pharmacokinetics (PK) Evaluation of a COVID-19 Therapy in Healthy Volunteers
- Access to regulatory insights that aided approval of proposal
- Documentation for submission to health authorities completed in 2 weeks
- Successfully guided DCG(I) approval for Phase I study
- First subject initiation from DCG(I) approval receipt was within three weeks
- Quick turnaround of clinical conduct, Bioanalytical, Pharmacokinetic evaluation, while ensuring quality
- Flexible framework that allows rapid implementation of on-going demands
- Effective and efficient clinical trial run using near real time insights
- Adherence to timelines and costs
The synopsis to proposal to protocol finalization were completed within 2 weeks
2) Safety and Efficacy for Adjunctive Therapy:
A mid-sized pharma needed to evaluate the Safety and Efficacy of an adjunctive therapy to standard of care, in comparison to standard of care alone, in the Acute Treatment of moderate to severe COVID -19 patients
Operational Approach to Evaluate the Safety and Efficacy of Mid-Size Pharma’s Adjunctive Therapy for Moderate to Severe COVID-19 Patients
- First-Person-In (FPI) achieved in 30 days from the time of study award
- Sites activated within 20 days from the study award
- Recruitment of patients ahead of time
- Effective remote monitoring
- Close coordination with Data Management, Medical and Lab
- Real time data dashboards for quick decisions on the study
Appreciation received from client and now we are their preferred partner for several of their ongoing COVID-19 studies
3) Safety and Efficacy of an existing Innovator Antiviral product
Navitas Life Sciences was required to conduct a double-blind randomized study among moderate to severe COVID -19 patients to generate efficacy/safety data that was to be submitted to the U.S.FDA.
Evaluation of the Safety and Efficacy of an existing Innovator Antiviral product for Moderate to Severe COVID-19 Patients
- FPI achieved in 15 days from receiving U.S.FDA feedback
- Sites trained and set up completed within 15 days from the study award
- Set up of OneClinical Analytics Platform prior to site activation
- 100% on-time completion of key
- Recruitment of patients as per the study plan and timelines
- Effective remote monitoring at site level maintaining high quality standard
Study planned in the Middle East with 3 sites
4) Safety and Efficacy Clinical Trials for a Combination Therapy on Moderate COVID-19 Patients
A multinational mid-sized pharma company based in India needed an end-to-end clinical trials partner to evaluate a randomized, open label, 8-treatment arm clinical trial to evaluate safety and efficacy of four marketed drugs in the acute treatment of COVID-19 patients. The study needed to be completed within 8 months, on 167 randomized patients from 10 sites across India.
Optimized Safety and Efficacy Clinical Trials for Mid-Size Pharma’s Combination Therapy on Moderate COVID-19 Patients
- First-Patient-In (FPI) achieved within 28 days of study award
- Sites activated within 20 days of study award
- 100% on-time completion of key milestones
- On-time Patient Recruitment
- High Quality site level
- OneClinical® was used for near real time data insights
Appreciation received from the client, with Navitas Life Sciences chosen as their preferred partner for multiple ongoing COVID-19 studies.
Navitas Life Sciences played its part in taking medical advancement in COVID-19 therapy forward, identifying safety and efficacy of multiple drug products on patients with COVID-19 symptoms. This reinstates our long-standing efforts to improve global healthcare through well planned and managed clinical trials.