Keeping your trial on track in an evolving environment.
ICON has adapted its services to support sponsors during this time; offering remote monitoring where on-site visits were not permitted, providing additional support to get IMP to patients and pre-recording investigator meetings because of travel restrictions. Find out more about services to minimise disruption below.
ICON is proud to be supporting clients and government organisations in the search for treatments and vaccines for COVID-19. Read more about our expertise in this area.
ICON mobilised a large global team of therapeutic and operational specialists to partner on the implementation of Pfizer‘s and BioNTech’s strategic plan and framework for the monitoring of the trial, which included a high level of remote clinical monitoring and source data verification.
Our regulatory experts are assessing the clinical trial environment on a day-to-day basis to ensure patient and employee safety is protected in operational activity and is aligned with regulatory and government guidelines (Letter from ICON CEO). Where feasible and safe we are finding ways to minimise disruption of research programmes by being proactive and innovative.
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.Read the whitepaper
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.Read the whitepaper
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.Watch the video
In this webinar broadcast on 6 May, 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.Watch recording now
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 (PDF), which examines COVID-19 updates from regulatory and health authorities around the world. Subscribe to ensure you continue to receive each month’s issue.
Coronavirus Observatory: aggregated updates from all regulatory authorities via Twitter.Register for the Regulatory Intelligence Newsletter
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.
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.Read the whitepaper
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.Download factsheet
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.
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.Download factsheet
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.Download factsheet
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:
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.
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.Watch the video
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.Learn more
The race to provide vaccines and treatments for coronavirus has seen a number of COVID-19 drugs reach the market in record time.
An article exploring the challenges and risks to statistical integrity and how they can be mitigated.
An outline of best practices that can keep trials running at optimal speed and efficiency, and the benefits of adopting a strategic partnership.
ICON CEO Steve Cutler, discusses running the Pfizer / BioNTech vaccine trial, and how it proved the value of partnership, and the key role of technology.
The approval of the messenger RNA (mRNA) COVID vaccines marked the first time mRNA vaccines have been authorised for use outside of clinical trials.
The COVID-19 pandemic has greatly impacted the IVD industry, including travel and social distancing restrictions, creating hassles and stalling NB designation processes.
The COVID-19 pandemic has been a catalyst for change in cancer research, forcing a shift towards remote monitoring, virtual arms and other uses of digital tools.
The COVID-19 pandemic has forced the clinical trials industry to accept and accelerate the use of digital health technologies to alleviate disruptions and mitigate risks caused by the spread of the virus.
Cyber attacks have increased dramatically during the COVID-19 pandemic. Opportunistic cyber criminals can use the current pandemic to steal intellectual property and patient information.
The pandemic is affecting how clinical trials are managed, not just in terms of patient recruitment and immediate patient care but also in terms of data collection, analysis and safety reporting.
For IVD manufacturers, the emergence of a novel virus is challenging as the detection of such viruses require quickly developed, novel diagnostic solutions.
The success factors that can keep pandemic respiratory vaccine trials running at optimal speed and efficiency.
Need for rapid diagnostic testing to identify and track people infected by or exposed to coronavirus.
A dynamic market and evolving regulations.
Adapting clinical trial protocols can help to keep participants enrolled and receiving treatments and assessments.
Impact of COVID-19 pandemic.
Patients with cardiovascular disease are particularly susceptible to respiratory infections.
A look at the potential impact of Coronavirus.