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In June 2021, McKinsey published an article on the decentralization of clinical trials. The report highlighted the following trends:

  • Key benefits of virtual trials (read our eBook on virtual clinical trials here)
  • How the pandemic accelerated the digital transformation of clinical trial processes
  • Why improving the patient and physician experience is critical?
  • The role of data in monitoring the effect of trial drugs on patients
  • How AI, NLP and other emerging technologies are aiding clinical processes

Consultants at Deloitte believe that sponsors and CROs who boldly embrace digital solutions can address clinical and operational challenges better and tap opportunities faster. It further recommends a three-pronged approach to managing trials:

  • Automate repetitive processes using the right digital tools
  • Use existing tools to the fullest extent
  • Identify gaps (in terms of digitalization) and buy/partner with technology vendors

Further, the regulatory environment is also constantly changing, with implications on data, governance, and security, among others. According to CenterWatch, some of the significant areas affecting clinical research include:

  • The use of artificial intelligence (AI) in research
  • Privacy regulations and appropriate documentation of clinical trials
  • Increasing interest in the use of real-world evidence (RWE) and data (RWD); and managing expectations around using such data

These requirements are emerging from the underlying need for clinical research:

  • To become more patient-centric
  • Reduce burden on sites
  • Improve data accuracy
  • Provide access to real-world data

To remain competitive and meet regulatory requirements, a few key trends CROs and sponsors need to watch out for and adopt in 2022 include:

Trend #1 – Digital Therapeutics

Digital therapeutics is about embracing new technologies to not only streamline operations but also deliver therapy and care. A few mainstream examples include Apple’s innovative health-focused wearables, Amazon’s Alexa capability to respond to simple questions around health and Google’ssupport for healthcare companies use AI/ML to deliver patient care. At the simplest level, smart phones are being used to deliver notifications – to remind patients to take their drugs. Some of these wearables or digital therapeutic products have to be approved by regulators.

Combining the digital component with drugs will have a significant impact on improving the outcome of therapeutics. In addition, the digital component can help with enhancing patient engagement and facilitate better disease management by providing real-world data on the efficacy and safety of the drugs.

Trend #2 – Dynamic Clinical Trial Designs

The earlier model of patients having to visit the trial site and the same patient being used for many trials is fast changing thanks to digital intervention. Enabling virtual participation can help overcome recruitment and retention challenges. This can improve patient engagement, expanding the reach to identify more potential recruits for trials with minimal disruption to patients’ lives.

Trend #3 – Data Science for Drug Discovery and Development

Data science became a key trend in 2021 for drug discovery and development in the pharma industry. This is expected to be an important trend this year too, with cloud-first tools becoming important to accelerate adoption and integrate with existing workflows.

In addition, natural language processing (NLP) will be another important technology that will enable CROs and sponsors to extract insights from unstructured data as well.

Trend #4 – Pharmacogenomics

Genetic mutations are an important cause of many diseases, and this is emerging as another important trend. The increasing interest in this area will see a corresponding increase in the collection of genomic data from a genetically diverse population and linking this data to deep phenomic data such as structured EHR, NLP-extracted unstructured EHR, claims, lab results, and wearable device data.

Trend #5 – Image Analytics in Drug Development

Advanced Imaging Analytics or Radiomics can help with better forecasting of patient outcomes. For example, it can provide insights into tumors by analyzing traditional images such as CT and PET scans using AI algorithms.

In addition, Radiomics can help personalize the prognosis of patients using data to assess the progress of the disease.

Trend #6 – Adoption of Deeper AI technologies

We expect the pharma industry to take advantage of cutting-edge technologies like NLP, computer vision and machine learning across the drug development lifecycle. We believe that well-planned use of these technologies with shorten the overall time required for all clinical processes.

Trend #7 – Precision Dosing

Precise dosing of novel therapeutics to prevent adverse drug events will help reduce hospitalizations (from adverse reactions to specialty drugs). The ideal dosage can be calculated based on real-world data, aided by sophisticated algorithms and data models.

ComplianceQuest CTMS: Why it is an ideal solution?

CQ Clinical is your ‘one-stop-shop’ for all clinical operations and clinical quality needs.

CQ Clinical, powered by Cloudbyz, is a centralized solution to:

  • Streamline end-to-end clinical trial operations
  • Have data visibility across the lifecycle
  • Automate processes across all four phases of clinical trials including study-start-up, patient recruitment, budgeting, pharmacovigilance
  • Ensure better collaboration among CROs, sponsors, sites, and all other stakeholders

Also, by integrating ComplianceQuest’s EQMS with the CTMS, one can drive compliance, quality and continuous improvement across the clinical lifecycle.

CQ CTMS enables decentralizing clinical trial management solutions, providing greater control and efficiency in data flow and workflow management. It provides access to quality data for the studies, leading to efficient use of time and resources, saving costs, and increasing operational efficiency. It facilitates the management of sites, patient enrollment, documentation, events management, achieving and tracking milestones, site visit reports, finances, inventory, among others. With faster access to real-time data, tracking and managing studies from start-up to closure becomes easier while also improving compliance with Good Clinical Practices (GCP), 21 CFR Part 50, and 21 CFR Part 11.

To know more about the ComplianceQuest CTMS solution visit:
https://www.compliancequest.com/clinical-ctms/

Request a demo here: https://www.compliancequest.com/online-demo/

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