Application Notes & Case Studies
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Regulatory Portfolio Management: From Bad To Gold
10/30/2023
Uncover how a multiphased approach helped a small biotech to organize its programs so that it could efficiently make decisions, timely adapt to changes in strategy, and better understand current activities.
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Successful Management Facilitates Marketing Application Prep
10/30/2023
See how this small clinical-stage biotech team was able to adopt greater responsibility and accountability and embrace the criticality of structure and timelines through evaluation and mentorship.
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Fast-Tracking Your Product Development With An IDP
10/30/2023
Explore how a customized Integrated Development Plan assisted in the removal of guesswork and obstacles from a startup's development roadmap, enabling it to move with speed and remain competitive.
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A Successful Pre-IND Enabling Next Stage Of Development
10/30/2023
Confronted with challenges, unearth how after receiving regulatory consulting services, this biotech was able to evaluate deficiencies in its development program, augment leadership and technical expertise in its application review, and more.
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Effective Clinical Evaluation Preparation Enables EU MDR Compliance
10/30/2023
Uncover how one company was able to ensure that its European products remained on the market through outsourced preparation of high-quality Clinical Evaluation Reports (CERs) for submission to Notified Bodies.
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Global Comprehensive Audit Support
10/26/2023
Uncover how a pharmaceutical company and its strategic partners were able to provide oversight of key performance indicators relevant to the pharma's business model, which enabled escalation and remediation of any concerns.
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Best Practices For Changing From One eClinical Vendor To Another
10/24/2023
Switching solution providers mid-study isn't uncommon. But how can teams avoid schedule delays, interrupted operations, and errors? Learn best practices from this example by Signant Biotech.
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Breakthrough Therapy Designation Accelerates Oncology Treatment Development
10/24/2023
Find out how this evidence-generation company's solutions and scientific expertise enabled early and successful regulatory submission for a novel oncology therapeutic.
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Moving From Clinical Development To BLA Through Strategic Planning
10/23/2023
Uncover how a small biotechnology company was able to successfully file its Biologics License Application submission to the U.S. Food and Drug Administration after undergoing several personnel losses and shifts.
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Enhancing Oncology Trials With Clinical Platform Solutions
10/18/2023
This example involves a top 10 pharmaceutical company and explores how they were able to improve oncology trial efficiency, safety, patient experience, and more using a platform approach.