Celebrating International Clinical Trials Day - May 20th 2023

International Clinical Trials Day is an annual event celebrated on 20^th May 2023 to acknowledge the pivotal role clinical trials play in advancing medical science and improving patient outcomes.

Clinical trials can be traced back to the time when early healers and physicians experimented with various treatments and remedies. However, it was not until the 18th century that clinical trials, as we know them today, began to take shape. British naval surgeon James Lind is often regarded as the pioneer of clinical trials. In 1747, he conducted a groundbreaking study to determine the effectiveness of citrus fruits in combating scurvy among sailors. This work laid the foundation for systematic experimentation and paved the way for future advancements in medical research.

Navitas Life Sciences SpearHeads Efficient Clinical Trials

Navitas Life Sciences supports small to large pharma, biotech and devices companies, generics manufacturers, and U.S federal agencies like Centers for Disease Control and Prevention (CDC) and The U.S. Department of Defense (DoD), delivering platform-driven full-service Clinical, Regulatory and Safety solutions and services.

A technology led full-service CRO, Navitas Life Sciences has 30+ years of rich experience across 600+ phase I-IV clinical trials, 20+ therapeutic areas including oncology. Our trial expertise is augmented by our proprietary OneClinical^® Analytics, a platform that delivers trial oversight and key data insights that aid in better decision making for efficient clinical trial management.

How Clinical Trials Help Improve the Life of Patients and the Medical Community

Clinical Trials have a wide value base and enrich medical science and the patient community at large. They have multiple benefits including:

1) Advancing Medical Knowledge while leveraging the latest methods and technology:

Clinical trials have emerged as the gold standard for evaluating the safety and efficacy of medical interventions, ranging from new drugs and therapies to medical devices and preventive strategies. They serve as a essential bridge between laboratory research and real-world patient care. By subjecting investigational treatments to rigorous testing in diverse populations, clinical trials generate robust evidence that guides medical decisions, informs regulatory approvals, and ultimately enhances patient care.

• Clinical trials employ well-designed protocols and methodologies to ensure the validity and reliability of the results. They are constantly evolving to adopt innovative trial designs such as adaptive trials, basket trials, decentralised trials and remote monitoring.
• Navitas Life Sciences utilises its digital solutions and AI platform, OneClinical^® Analytics to provide near real time data and remote monitroing practices for greater flexibility, patient centricity and improved trial run.
• Clinical trials are instrumental in evaluating the safety and efficacy of new drugs, therapies, medical devices, and procedures.
• They enable researchers to compare different treatment options to determine which interventions work best for specific patient populations.
• Clinical trials increasingly incorporate real-world evidence, which includes data from electronic health records, wearable devices, and patient-reported outcomes. This integration allows researchers to gather insights beyond the controlled trial environment, providing a more comprehensive understanding of the effectiveness and safety of interventions in real-world settings.
• Data Analytics and Artificial Intelligence: The integration of data analytics and artificial intelligence (AI) in clinical trials enables researchers to analyze vast amounts of data more efficiently, uncover hidden patterns, and generate valuable insights. AI algorithms can assist in patient selection, risk stratification, and predicting treatment responses, enhancing trial efficiency and improving patient outcomes.

“According to projections, the market for Real-world Data (RWD) is anticipated to grow steadily at a Compound Annual Growth Rate (CAGR) of 7.4% between 2022 and 2029, reaching a value of $1.66 billion by the end of the forecast period. Real-world data (RWD) has emerged as a powerful resource for companies operating in the life sciences industry, including pharmaceutical, biotechnology, and medical device firms. Clinical Registries offer a means of gathering real-world evidence and supporting health care and research collaboration and dissemination. These registries enable the ongoing collection of clinical data within a specific population, and they have the potential to provide essential guidance to influence clinical decision-making in both research and patient care.”

Dr Yun Lu,
Chief Science and Innovation Officer

We build bespoke teams of highly skilled Statistical Programmers (both US-based and Global Programmers), Biostatisticians, and Data Managers. Our expert-driven Statistical Programming, Biostatistics, and Data Management services support our sponsors in reaching successful clinical trial outcomes. Our blended team of highly skilled experts fuel every FSP engagement by providing complete data support or by augmenting existing teams.

“I have been involved with clinical trials for over 30 years, starting in data management and moving to project management and staff management. I am involved in the analysis of study data before it goes for approval. It has always been rewarding work, especially when a drug I have worked on is approved for use by FDA. The true meaning of the work is most appar4ent when you meet someone who is using a drug you helped to get approved and it has improved their quality of life.”

Kathy Greer,
Executive Vice President,
NDS-US

2) Improving Patient Outcomes and Delivering Support for Better Care:

Clinical trials have played a transformative role in the prevention, diagnosis, and treatment of diseases. They have been instrumental in the development of life-saving drugs, breakthrough therapies, and innovative medical devices. From the discovery of antibiotics and vaccines to the advancements in precision medicine and gene therapies, clinical trials have revolutionized healthcare by extending life expectancy, improving quality of life, and providing hope to millions of patients worldwide.

Navitas Life Sciences has been supporting clinical trials across 20+ therapeutic areas, including oncology.

3) Accelerating Drug Development and faster Market Reach:

In addition to their impact on patient care, clinical trials are vital for the pharmaceutical industry and regulatory agencies. These trials help pharmaceutical companies gather essential data required for regulatory approvals and commercialization. By fostering innovation and expediting drug development, clinical trials contribute to the timely availability of safe and effective treatments, addressing unmet medical needs and combating global health challenges.

Navitas Life Sciences leverages its vast experience, expertise and technologicl support to drive innovation in clinical trials, resulting in cost and time efficient clinical trials.

Regulatory and Pharmacovigilance Support

Regulatory support and pharmacovigilance play a vital role in ensuring safety of drugs and medical devices. Let us look at their significance and importance on International Clinical Trials Day:

• Regulatory support is essential in establishing guidelines and frameworks that prioritize patient safety during clinical trials. Regulatory authorities enforce stringent standards and protocols to protect the rights, welfare, and well-being of trial participants.
• Regulatory bodies establish ethical guidelines and principles that govern the conduct of clinical trials.
• They provide guidance on regulatory requirements, review trial applications, and collaborate with international counterparts to harmonize standards. By streamlining the approval process, regulatory support enables timely initiation of trials, which is critical in addressing emerging healthcare needs and bringing innovative treatments to patients.
• Regulatory bodies set standards for data management, quality assurance, and good clinical practice (GCP) to ensure the integrity and reliability of clinical trial data.

With a rich legacy of experience and expertise, Navitas Life Sciences serve as trusted advisors and provide tailored End-to-End Regulatory solutions grounded in industry best practices

Pharmacovigilance and Safety Monitoring: Pharmacovigilance, the science of monitoring and evaluating the safety and effectiveness of medical products, is of paramount importance. Regulatory agencies oversee pharmacovigilance efforts to detect and manage adverse events associated with investigational treatments. Robust pharmacovigilance systems ensure that any potential risks or side effects are promptly identified, reported, and appropriately addressed, enhancing participant safety and the reliability of trial results.

“As we celebrate World Clinical Trials Day, it's important to recognize the critical role of Pharmacovigilance services in ensuring the safety and efficacy of healthcare and drug products. At Navitas Life Sciences, we are committed to supporting pharmaceutical and biotechnology companies in navigating complex regulatory requirements and bringing innovative treatments to patients around the world.
There has been a growing trend towards the digitalization and automation of Pharmacovigilance and Regulatory activities. The use of digital tools and platforms can help to streamline processes, reduce errors, and improve efficiency.
Our team of experts work tirelessly to ensure that every product meets the highest regulatory standards, ultimately improving public health and saving lives. Together, let's continue to prioritize the health and well-being of people worldwide.”

Marty Boom,
Global Head of Reg. & PV

Navitas Life Sciences has been at the forefront of Pharmacovigilance for 30+ Years. We understand the crucial need for Life Sciences organizations to leverage technology to automate processes, use data to drive insights and hence, improve efficiencies while supporting the safety profile of their drugs.

Our Industry leading Pharmacovigilance and Regulatory Networks

Joining one of our industry leading networks can help raise the profile of the company and the team. The networks provide a chance to meet peers and be part of an independent sounding board to test and validate the latest thinking, and uncover industry insight to develop compelling, yet pragmatic strategies to provide business value and meet the needs of patients, payers, and prescribers.

Regulatory support and pharmacovigilance are indispensable components that ensure patient safety, maintain ethical standards, streamline trial processes, and monitor safety and efficacy.

International Clinical Trials Day recognizes and appreciates the remarkable contributions of clinical trials to medical science and patient care. As we celebrate this day, let us renew our commitment to supporting and advancing clinical research, with the shared goal of achieving better health outcomes for people in need.

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