Document Migration

WHITE PAPERS AND CASE STUDIES

• Developing Effective Procedures

  Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.

• Medical Writing Support Relieves A Burdensome Review

  Unearth how medical writing and project management teams were able to streamline the development and review of a critical marketing application document.

• Study Start-Up Challenges: Hard Realities, Effective Strategies

  Launching a study is complex, and the time between protocol approval and the first patient visit has increased dramatically. How can companies reverse this trend and accelerate study start-ups?

• Achieving Faster Timelines And Cost Savings Through Digital Validation

  Examine how the Project Ready program was leveraged to streamline validation processes for a CDMO, resulting in a 25% reduction in budget and faster project completion.

• Rethink What You Should Expect From Your System: Modern Batch Solution

  Today’s dynamic manufacturing climate presents multiple challenges, forcing manufacturers to compare traditional and modern batch and rethink what to expect when choosing a system.

• Expand Bandwidth With A Trusted Regulatory Writing Partner

  Find out how a mid-size biotech lacking the bandwidth, expertise, and resources to independently handle its regulatory writing requirements overcame this challenge.

• CDMO Accelerates Contract Manufacturing With Electronic Batch Records

  A prominent CDMO sought a specialized software solution to streamline and accelerate its manufacturing processes, enabling the efficient production of complex, customized products in record time.

• Biomanufacturing Readiness: A Validation Model For Multiproduct Facilities

  Optimize your validation strategy to meet evolving regulatory demands and product complexities with a scalable, efficient framework that accelerates facility readiness and ensures consistent quality.

• Exploring Open Collaboration In The Water Industry

  This white paper will explore the necessity of open data, open software, and open collaboration in the water sector. 

• Rethinking Clinical Operations: A Smarter, Faster Playbook For Trial Success

  The CRO-sponsor partnership is now strategic, addressing communication gaps and fragmented systems to improve efficiency. Joint governance, real-time tracking, and unified technology accelerate complex trial execution.

• Manufacturing Of Cytotoxic And Non-Cytotoxic Drugs In A Multiproduct Facility

  The experience and expertise of the CMO is crucial to avoid the risk of cross-contamination of the drug product, as failures or weaknesses in this process can pose risk to the end-user.

• Patient Perspectives On eConsent

  Explore how eConsent enables participants to engage meaningfully with consent documentation, addressing information dissemination, explanation, and recall challenges.