License Management

Secure Your Study’s Success with Efficient License Management

Avoid study delays, legal and financial liabilities by making sure your questionnaire licenses are done in time.

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License Management

License Management in Clinical Trials

 

License management in clinical trials is crucial for ensuring the timely and compliant use of questionnaires and other licensed materials. Managing these licenses effectively prevents study delays, legal issues, and financial liabilities. As part of the preparatory phase, sponsors must secure appropriate licenses before patient enrollment begins, particularly when electronic implementations are involved.

Avoid Delays with Proactive License Acquisition

 

To avoid potential delays with the first patient in (FPI) date, it is essential for sponsors to engage early with the licensing process of the study questionnaires. This includes obtaining the license and the source files from authors or their representatives and ensuring these are delivered to the ePRO vendor in a timely fashion.

Timeliness in these actions is crucial for maintaining the project timeline and avoiding costly setbacks.

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Navigate Complex Licensing Requirements

The licensing process often involves negotiating with authors who have established specific procedures for applying for a license. This process typically covers the original instrument and any necessary translations for international trials. It may also include the adaptation of these instruments for electronic platforms, requiring thorough review of both the original and translated versions on the screens used in the study.

Often there is more than one license required per author. Vendors and sometimes CROs who are involved in the project will need to sign an agreement too.

Efficient Licensing Through Technology and Experience

 

SAFIRA employs a sophisticated experience database complete with a workflow and tracking process designed to optimize the licensing experience. This system ensures that all licenses are managed effectively, from application to approval, facilitating a smoother, faster transition to study start-up and ongoing management throughout the trial’s duration.

By integrating these robust license management practices, clinical trials can achieve greater efficiency, compliance, and overall success, ensuring that all necessary materials are legally compliant and available when needed.

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License management for clinical trials

Benefits

Expertise in Streamlining Licensing Processes

With our extensive experience and a developed network within the author community, SAFIRA helps expedite the licensing process. Their deep understanding of the nuances involved in obtaining and managing questionnaire licenses allows them to navigate the complexities efficiently, ensuring that all legal and regulatory requirements are met without delay.

Enhanced Compliance with Intellectual Property Rights

Proper license management ensures that all materials used in clinical trials, such as questionnaires and assessments, comply with intellectual property laws. This protects the trial sponsors from legal disputes related to copyright infringement, which can be costly and damage the reputation of the research entities involved.

Scalability Across Multiple Regions

Effective license management facilitates the scalability of clinical trials across different geographical regions. By securing appropriate licenses for all required translations and regional adaptations, trial sponsors can smoothly expand their studies to include diverse participant populations without legal barriers.

Cost Management and Forecasting

Good license management helps in better cost control and financial forecasting for clinical trials. By understanding and planning for licensing costs in advance, organizations can budget more accurately and avoid unexpected expenses, which can be particularly high when dealing with multiple instruments or extensive translations.

Long-term Access and Usage Rights

By negotiating comprehensive licensing agreements, clinical trial sponsors can secure long-term access and usage rights for the clinical instruments and data collected. This is particularly beneficial for long-duration studies or follow-up phases where continued access to standardized instruments is required for comparative analysis and ensuring consistent data quality over time.

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