Clinical Trials Trends for 2022 that you need to Know

As we enter 2022, clinical trials continue to forge ahead with the latest innovations and discoveries to ensure transformational healthcare for everyone in need. What are the latest trends that pharmaceutical and biotechnology companies need to look out for this year? To find out the answer to this question, our leaders provide expert insights to help prepare for the future of clinical trials.


Srinivasan HR,

Chief Executive Officer,
Navitas Life Sciences

The Great Healthcare Acceleration

"The past couple of years saw a massive change in the way clinical trials were run and in the need for improved healthcare. Technology-led innovation has seen an exponential uptake, with McKinsey estimating that between $350 billion to $410 billion in Annual value can be created by utilizing such innovation to provide individual care. Clinical trial protocols have been quick to imbibe these innovations with oximeters, e-Consent forms, and tablets used for data collection. According to Global Data, a dramatic 93% increase in the uptake of decentralized clinical trials is expected in 2022, when compared with numbers in 2020.

Apart from COVID-19 vaccines and therapeutics, 2022 will witness clinical trials that study the use of monoclonal antibodies, CRISPR-based gene therapy, and even oncolytic viruses for multiple conditions including cancer. Diabetes, cardiovascular disease as well respiratory diseases are among the conditions that are expected to be most studied in 2022.

Navitas Life Sciences’ futuristic approach to clinical trial management enabled investments in technological innovation over several years, spearheading effective data management and near-real-time information-led decision making. Our vast experience and expertise across 20+ therapeutic areas and stringent adherence to protocols have garnered repeated engagements with leading pharmaceutical companies and a conclusive “without any observations for discussion” post remote record review by US-FDA."

Clinical Research

With over 30 years of experience in conducting clinical trials, we understand your key challenges and have established systems to run a successful trial. Right from phase I to phase IV, we support your organization from startup to closure, and beyond, with our regulatory insights and quality approach.


Sowmya Kaur,

Head, APAC Navitas Clinical Research and Global Client Solutions,
Navitas Life Sciences

“Navitas Life Sciences couples key insights with the best strategies to run efficient clinical trials. The most critical factor that will drive the future of clinical trials is investments in state-of-the-art technology platforms, that bring to dominance decentralized trials and hybrid trials. GlobalData has reported a likely 28% increase in decentralized clinical trials when compared to numbers in 2021, highlighting the significance of established yet agile partners in the ever-evolving clinical trial industry.

The industry will see biopharma companies accelerating the consumption of diverse data sets to further define and segment patients as they address unmet patient needs. Biopharma companies and CROs will also advance capabilities to support cell and gene therapy trials and scale infrastructure and capabilities to support the same”


Yun Lu, PhD,

Director, Data Management and Standards

"Decentralized Clinical Research – Navitas Life Sciences’ Direct-to-Patient Service

Navitas Life Sciences has assembled an exceptional clinical research and data science team with the resources to respond to the needs of the increased decentralized clinical trials and research, in line with the current industry requirements. Important to this direct-to-patient service, Navitas Life Sciences offers:

  • eConsent modules with disease area sensitivities in mind.
  • Navitas Life Sciences’ clinical monitors, working in conjunction with data management, ensure data integrity and regulatory compliance through remote monitoring, risk-based monitoring, and risk-based data management and quality management
  • Patient-centric eConsent, ePRO and patient-facing reporting to promote patient engagement and patient self-management, and modernize the patient experience
  • From clinical research and disease care management to data exchange and mobile applications, our team is adept at health information integration and connectivity within the research, health and standard care market"

Generics Development

Bioavailability (BA) and Bioequivalence (BE) studies are carried out for developing a new formulation or for marketing a generic drug. In order to market a generic drug, BABE studies are required for approval from health authorities like US FDA. The drug that is being tested is studied against a well-known and commercially available drug, at the same concentrations and under conditions that are similar. Companies file their Abbreviated New Drug Application (ANDA) according to 505 (j) or 505b (2) to the US FDA for marketing authorization in the US. The selection of the right clinical research organization is vital for a successful market launch.


Ayaaz Hussain Khan, PhD,

Global Head, Generics,
Navitas Life Sciences

“The pandemic brought in a lot of changes including the need for dynamic clinical trial designs that allow greater flexibility, thereby engaging more patients and accelerating clinical trials. 2022 will also see a greater focus on pharmacogenomics and the use of patient data from wearable devices, paving the way for personalized healthcare.

Navitas Life Sciences has been agile in adapting to changing needs while ensuring regulatory compliance. The U.S Food and Drug Administration (FDA) conducted a remote review of our Generics Business Unit’s Bioequivalence Studies, with 4 inspectors from their US office (Office of study integrity and surveillance, Division of Generic Drug Study Integrity) across 4 days, covering study data, systems, processes, and controls. Navitas Life Sciences fully and successfully supported the review with seamless connectivity and data provision with scientific discussions and deliberations, culminating in a successful closeout without any observations for discussion.”

Data Sciences

A functional service provider for your biometric needs. Navitas Life Sciences builds bespoke teams of highly skilled Statistical Programmers (both US-based and Global Programmers), Biostatisticians, and Data Managers.


Paul Gilbert,

Chief Operating Officer,
Navitas Data Sciences

“2021 has been an incredible year for Data Sciences at Navitas Life Sciences. We are excited for another year of double-digit growth thanks to our range of flexible Functional Service Provider models, especially the FSP-Hybrid model. During 2021, we saw our sponsors increasingly take advantage of our global footprint, and we anticipate this trend to continue into 2022.”

Regulatory Affairs and Pharmacovigilance

Strategic Partnerships to optimize your regulatory processes, drive first-time-right submissions, and enable life cycle management. With a rich legacy of experience and expertise, we serve as trusted advisors and provide tailored solutions grounded in industry best practices.


Marty Boom,

Global Head, Regulatory & PV,
Navitas Life Sciences

"2022 is set to be thrilling for regulatory and pharmacovigilance processes, with a focus on enhancing processes with technological innovations like AI, ML, and RPA. There will be an increased need to step up technologies with a risk of becoming obsolete otherwise. Service providers who are agile and swift in moving towards such advancements will forge better partnerships and drive growth for the next few years. The regulatory affairs outsourcing market from 2021-2026 is expected to grow by 4.63 Billion USD, reflecting exciting times for the BPO market.

The conduct of clinical trials in Europe will also see a significant change with the Clinical Trials Regulation (Regulation (EU) No 536/2014) expected to come into effect from 31st January 2022. According to this regulation, a Clinical Trials Information System (CTIS) will now ensure supervision and assessment of clinical trials in Europe.

Navitas Life Sciences is your experienced partner for your end-to-end regulatory needs with 128000 eCTD Submissions, 27000 NeES Submissions, 36000 Paper Submissions, 160 Regulatory Professionals, 200 Customers, 5 Technologies, and 100 Health Authorities."


Mallikarjun R,

VP - Regulatory Services,
Navitas Life Sciences

“Regulatory affairs services are paramount from the design of the clinical trials, IND stages through NDA, and post-approval to accomplish the First-Time-Right Submissions to global markets especially direction from regulatory strategist, CMC, Labeling / Promotional specialists are needed. Navitas with its spread in North America, South America, Europe, APAC, and Australia gives you a significant spread, which companies must invest considerably in to get such skill sets. At Navitas, you get expertise at a reasonable cost.”


Sivanandam B,

Associate Vice President,
Navitas Life Sciences

"Technology in the life science industry plays a vital role in transforming business. Due to the COVID-19 pandemic, the life sciences industry, that has traditionally been plagued by inefficient and time-consuming manual processes, is fast embracing the technology solutions to help drive fundamentally better outcomes. Technology is utilized to enhance processes and to build efficient systems that better manage regulatory compliance. The life sciences community is now using some level of automation across different processes. The trend expected in the forthcoming year is to explore or escalate the usage of automation technologies like Structured content management, Predictive analytics, RPA (Robotic Process Automation), ML (Machine Language), and AI (Artificial Intelligence), in many regulatory areas like, RIM, content management, Labelling, etc. Leading life-sciences companies are discovering the potency of the cloud in enabling standardizing processes across global operations and analytics with data lake, among other benefits. We could see the trend in life sciences with a significant share of the industry’s IT investment spent towards these innovations, hence unleashing the power of NextGen technologies."

Industry Networks

Our industry-leading networks can help raise the profile of both your company and your team. Join your peers and be part of an independent sounding board where you can 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.


Louise Jebson,

Head of Consulting & NETS,
Navitas Life Sciences

“There will be a significant surge in the use of technology in clinical trials. Mobile technology and wearables for remote monitoring, 5 G and blockchain enabled virtual trial platforms for secure digital data collection and processing are just a few examples of high-impact solutions. These solutions would deliver superior outcomes in terms of feasibility, patient adherence/engagement, cost savings, and time to market.

Our industry-leading networks provide a platform for the life sciences industry professionals in Pharmacovigilance and Regulatory Affairs. We have recently secured our 100th company membership and continue to add to our portfolio of networks for Safety, Regulatory, and Labeling leaders from pharma and medical technology companies to partner and shape NextGen Device and Combination Product Safety.

Our recent forum events at the end of 2021 are testament to the success of our networks, with our team having successfully hosted 598 members from 60 companies, across 18 meetings, and with 32-member case studies being shared.”

Navitas Life Sciences is purposeful in supporting efficient clinical trials, helping sponsors stay competitive with near real-time data insights, vast clinical trial experience, and expertise.

To find out more about our service and solutions, reach out to us at This email address is being protected from spambots. You need JavaScript enabled to view it.