Clinical:

Increase the efficiency and effectiveness of clinical studies

Clinical Services

A challenging drug development landscape with immensely conservative trial success rates is faced with increasing trial complexity and escalating costs of bringing a drug to market. At the same time, opportunities abound amidst an enhanced regulatory focus on safety and efficacy of drugs, increased pressure on biotech and pharmaceutical companies to make medicines affordable, shifting focus to rare and ultra rare diseases, and the promise of next gen sequencing leading to personalized medicine.

Clinical trials have become increasingly complex to manage due to the need for deep domain expertise, large scale global trials, need for a well stratified patient pool, recruitment and retention issues, and a lack of harmonized systems and processes for accurate and timely analysis of data. Among other reasons, rising healthcare costs are a manifestation of the inefficiencies in the drug development process.

In this scenario, an effective clinical trial demands a deep understanding of how to identify and mitigate risks from start to finish; how to identify the right parameters to drive trial progress and stay patient-centric; and how to set up trial endpoints to ensure a meaningful study. The operational success and the long term impact of a clinical trial depends on the ability to deliver high-quality data, quickly and cost-effectively.

Navitas Life Sciences Is Here to Help

As a proven clinical services provider, we bring our rich experience from partnering with well over a 100 innovator and generic Life Sciences companies to conduct a significant number of studies, including Phases 2 – 4, NIS, Biosimilars, and BA/BE. We have been a partner of choice for bringing several life-saving drugs to market, and have worked across several therapeutic areas, with significant expertise in Oncology. Our expertise also encompasses stem cell therapies, and diagnostic imaging and contrast agents. With a global workforce of domain experts attuned to industry trends, we bring significant subject matter expertise, regulatory strategy for product development, audit ready infrastructure, a skilled and experienced delivery team, and technology platforms that ensure compliance and are genuinely architected to enhance efficiencies and reduce costs.

Our Services:

  • Consulting led: Navitas has worked with leading global biotech and pharma companies to deliver better outcomes across the value chain, including support for life cycle management of approved drugs.
  • Deployed cost effectively, anywhere around the world: Navitas ensures global delivery, with local accountability, compliant with international regulations.
  • Enhance your chance of success or help you to fail fast: Our innovative, proprietary technology platform, OneClinical, enables risk based quality management of clinical trials. User friendly dashboards identify and manage risks before they become issues.
  • Backed by decades of full-service expertise: Whether it’s a BA/BE study using our database of > 20,000 healthy volunteers; a pivotal, global, phase 2/3 study for marketing approval; a challenging Biosimilar study or a post-marketing study to obtain real world evidence, we have passionate staff who care about your study as much as you do.
  • Offer flexible and adaptable clinical operations and data management capabilities to meet your needs: traditional clinical operations as well as central/remote monitoring services that proactively identify and mitigate risks using actionable insights. Clinical data services including data management; stats/programming; data standardisation and medical writing. 

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