Clinical trials during COVID-19

Keeping your trial on track in an evolving environment.

COVID-19 vaccines: Post-authorisation safety surveillance

This whitepaper explores the multifaceted challenges of COVID-19 post-authorisation safety surveillance studies and how business intelligence tools can benefit these efforts. 

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Whitepaper: Implications of COVID-19 on statistical design and analyses of clinical studies

The COVID-19 pandemic presented a serious disruption in the conduct of clinical trials. In this whitepaper we discuss the challenges and risks to the statistical integrity of data as a result of these challenging conditions. 

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Whitepaper: Mitigating the impact of COVID-19 on cardiovascular trials

This whitepaper outlines measures that can be implemented in ongoing trials assessing cardiovascular-directed therapies to ensure the safety of participants, maximise retention and maintain trial integrity.

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Integrated Solution - COVID-19

Driven by regulatory guidance

ICON has developed an integrated solution that deploys functional services driven by overarching COVID-19 regulatory guidance. No two studies are the same so our operational teams are ready to work with you to review study-specific plans and adopt the services needed to reduce disruption to trial timelines and stay compliant.

Contact us today to discuss the challenges and deploy the solutions.

Related factsheet: Keeping your trial on track during COVID-19.

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Webinar recording: Keeping your trial on track

In this webinar industry experts present regulatory and operational insights on how to be proactive to protect patient safety and minimise disruption. Recent case studies show how creative thinking and collaboration can overcome challenges.

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Regulatory audit & guidance

ICON regulatory consultants work to provide global strategic and operational guidance on regulatory updates to support customers' clinical development programmes. They can help you navigate the evolving developments during COVID-19 including; variations in regulatory guidelines on clinical trial conduct, pharmaceutical export restrictions, and expanded compassionate access for COVID-19 related compounds.

Download: the latest issue of our Regulatory Intelligence Newsletter. Subscribe to ensure you continue to receive each month’s issue.

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Webinar: In-home clinical visits

In this webinar industry experts provide insight on planning and execution of In-home visits during COVID-19 and beyond, patient populations and study type considerations and current regulatory guidance.

Download our factsheet to find our how using these services can minimise disruption during COVID-19.

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COVID-19 impact on Health Technology Assessments (HTA) & reimbursement requirements

How will the changes brought about by the pandemic impact your existing pipeline of products? Will you need to adjust your existing HEOR evidence planning and timetables? Are there steps you can take to ensure that patients and providers will still have timely access?

Get insights and recommendations on navigating global market access requirements in this dynamic environment.

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Using historical control data as an alternative

As patients face shelter-at-home restrictions and quarantine, and sites redirect efforts to treat COVID-19 patients, it can be faster, more economical and more patient-centric to utilize historical real world data as a control option for some studies, particularly in rare diseases. This approach can help to maximize patients on active therapy and reduce the total trial population sample size. It can also be more appealing to patients and physicians, by reducing the need for patients to travel to sites.

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Protecting the patient and data integrity

Safety Reporting: The COVID-19 pandemic is intensifying an already complex regulatory environment and making compliant safety reporting more difficult. Find out how regulatory intelligence, pharmacovigilance expertise and automation can reduce risk and ensure compliance at this time.

Related Factsheet: Safety Reporting during COVID-19
Related blog: The impact of COVID-19 on pharmacovigilance

Data Monitoring Committees: The FDA and EMA have both acknowledged that Data Monitoring Committees (DMC) may have a part to play in overcoming some of the challenges that we are seeing in this evolving environment. A well-organised and properly constructed DMC will help to ensure patient safety, protect data integrity as well as support appropriate analysis and interpretation of the trial data.

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Ensuring continuity of IP to patients

In the current environment patient visits may be re-scheduled and protocols may need to be amended. Now is the time to check if your IRT system needs adjustment to ensure continuity of IP to patients.  Our IRT and Clinical Supply Management team are ready to advise you on strategies to mitigate risks and maintain flow of clinical supplies.

Download our factsheet to find out more about being proactive to reduce risk in clinical supply flow.

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Maintaining patient contact

Our Direct to Patient Contact solutions support patients or their caregivers in studies and disease management programs and can enable you to connect with patients during the pandemic. Built on our global clinical outcomes expertise, real world evidence experience and clinical cross-cultural language services expertise, we offer multi-faceted contact methods including email, SMS, phone, letter and in-app alerts to:

  • Facilitate the collection of patient reported data (COAs, QoL, drug/resources utilisation, safety outcomes)
  • Enhance patient engagement through flexible, customised approach based on patient preference
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Pre-recorded investigator meetings

Travel restrictions to protect healthcare professionals has understandably resulted in the cancellation of investigator meetings.  
FIRECREST digital solutions provide the option to pre-record meeting content and deliver remote site training to maintain reporting for compliance.

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Overview of COVID-19

A video explaining the origin, identification and symptoms associated with this coronavirus

The cause of the disease was later identified as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) a novel coronavirus belonging to the same family as SARS-CoV and MERS-CoV. Human to human transmission is thought to happen largely through close contact with infected individuals particularly through exposure to respiratory droplets or airborne aerosols.

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Remote monitoring

ICON have the processes, technology and experience to be able to shift to a remote monitoring model where regulation permits. In late phase studies our Site Management Associate (SMA) model is designed specifically for managing late phase studies, in multiple languages and cultures, to provide continuous site support throughout the world. This focused, one-on-one approach is designed to improve data collection, ensure high quality data, and enhance site and patient engagement, while significantly reducing late-phase study costs.

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COVID-19 blogs and media articles