Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
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SEARCH JOBSThe pharmaceutical industry is continuing to shift towards a more patient-centric drug development landscape and patient reported outcomes are increasingly becoming an important benchmark for regulators and payers to measure the quality of a new treatment. This shift has made Clinical Outcome Assessments (COAs) an increasingly necessary and often required tool to gather patient experience data in most trials today.
Electronic Clinical Outcome Assessments (eCOAs) offer a direct line to patients, capturing real-time insights about their experience with their disease, the trial, and a treatment’s impact on their quality of life. These digital tools provide patients a chance to be heard while providing sponsors with quantitative and qualitative data to track the influence and efficacy of a treatment.
However, creating and validating a COA in an electronic format from scratch for each study is a cumbersome process that can add months to the trial planning process, and even small errors can lead to costly setbacks. Sponsors can spend 12-16 weeks to create a new assessment in an eCOA system, validate it against standards, and qualify it with regulators. In many cases, revisions and delays add more weeks to this process, leading to missed deadlines. It also increases the risk that the questions they ask will vary from assessment-to-assessment, making it more difficult to compare results across trials or patient populations.
In the past, sponsors have repeatedly re-created standard eCOAs for every trial. But what if there was a better way that would reduce costs and timelines, and improve quality?
This is where a library of pre-configured, author approved, and validated assessments plays an important role. A library can shorten the time of implementation down to a matter of days in some cases and ensure consistency in the data being collected. However, for an assessment to be used in a trial, sponsors need to secure approval from the original author of the assessment and validate that the electronic version being used meets their requirements. This is a step that frequently gets overlooked, which creates hidden risks for the sponsor.
Obtaining validation from authors can be as simple as sharing and approving a screenshot review or it can become very complex if multiple iterations are required and there are communication delays. The process can require several rounds of back and forth as authors verify the version accurately captures the data as intended.
The uncertainty related to this review and approval process means it has the potential to delay trial start-up by weeks. And if sponsors or eCOA vendors fail to complete this step, they put themselves and their trials at risk of copyright infringement, leading to costly fines, punitive damages, and potentially render trial data corrupt or unusable.
Vetted assessments ready-to-go
The IQVIA eCOA library of assessments solves this problem, providing sponsors with instant access to pre-built electronic assessments to meet their research needs. The eCOA library features more than 1,000 electronic versions of assessments that are pre-configured within the platform. Of these, more than 150 eCOAs have already been validated and approved for use by the original authors, with more approvals being completed every month. By the end of 2021, 250 eCOAs are expected to be validated and approved, providing sponsors a diverse set of assessments that can be immediately implemented in trials across various disease categories.
IQVIA follows a rigorous due diligence process, to ensure the copyright holder has fully vetted these assessments in the library. Because there are many existing industry assessments, our team utilizes a weighted scoring system to prioritize approval of the most in-demand assessments for our library. The scoring is based on the following criteria:By analyzing these through our scoring system this ensures the most sought after eCOA assessments will be vetted, approved, and ready for use, reducing valuable time from the development process. In addition, IQVIA is partnering with many organizations and authors of assessments to foster collaboration that will ultimately help benefit sponsors.
A few examples of fully approved assessments in the IQVIA eCOA library include several PROMIS Measures, Oxford University’s Parkinson’s Disease Questionnaire (PDQ-39/8), and IQVIA’s Treatment Satisfaction Questionnaire for Medication (TSQM).
Having access to these vetted assessments means sponsors do not have to worry about potential delays from this process, which provides valuable flexibility in the event that late changes need to be made to the eCOA strategy for a trial. This ensures confidence that the selected assessments will capture the real-time insights needed to inform trial progress and demonstrate results, potentially speeding the journey to market.
The IQVIA eCOA library provides several key customer benefits including:Email us at ecoa@iqvia.com to connect with an expert on how our eCOA library can be used in your studies today.
Fast, flexible and proven, IQVIA’s industry-leading electronic clinical outcome assessment (eCOA) platform ramps up efficiencies, delivers real-time data, and sharpens insights through best-in-class technology and a better patient experience.
Explore our Frequently Asked Questions (FAQ) page to learn more about general industry eCOA topics and also specific details about our IQVIA eCOA solution.
In these short demo videos, learn more about some of the key capabilities within the IQVIA eCOA platform including how to easily create an assessment, utilize the AI design tool, access automated screenshots and documentation, export/import translations, and view study data and reports.
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