Whitepapers and Articles

  • Plan & engage early to manage the risks of risk management

    Plan & engage early to manage the risks of risk management

    Read More
  • Driving by Data: A Faster, Better Road to Market

    Driving by Data: A Faster, Better Road to Market

    Prevent Costly Delays.

    Read More
  • How to be Smart About Pre-IND and Other Meetings With the FDA

    How to be Smart About Pre-IND and Other Meetings With the FDA

    Read our strategies on how to be smart about pre-IND meetings and tips to reap the full benefits of meeting with the FDA.

    Read More
  • A Smart Global Regulatory Submissions Strategy is Flexible, Nuanced and Nails the Logistics

    A Smart Global Regulatory Submissions Strategy is Flexible, Nuanced and Nails the Logistics

    Do you have the right plan in place? Learn three critical components for successful global regulatory submissions.

    Read More
  • Strategies for Working with Global Regulatory Agencies

    Strategies for Working with Global Regulatory Agencies

    Early engagement with regulatory authorities can help boost regulatory success rates and also help shorten clinical development timelines.

    Read More
  • Understanding Regulatory Requirements in Today’s Accelerated Approval Environment

    Understanding Regulatory Requirements in Today’s Accelerated Approval Environment

    Even for drugs that may never reach market, Accelerated Pathways can help companies deploy resources more efficiently and make more timely, and cost-effective go/no-go decisions.

    Read More
  • Phase III Trial Failures: Costly But Preventable

    Phase III Trial Failures: Costly But Preventable

    This article examines reasons for the high failure rate of Phase III studies and innovative approaches companies can take to mitigate risk.

    Read More
  • Regulatory Handbook: Data Integrity: FDA And Global Regulatory Guidance

    Regulatory Handbook: Data Integrity: FDA And Global Regulatory Guidance

    Learn the newest trends and regulatory changes as we guide you through FDA and global regulations, guidance and reports on data integrity.

    Read More
  • FDA's Accelerated Pathways Are The New Normal

    FDA's Accelerated Pathways Are The New Normal

    Accelerated Pathways work if you work with them -- learn how.

    Read More
  • Smart Strategies for the Beginning and End of Drug Development

    Smart Strategies for the Beginning and End of Drug Development

    Read More
  • Early Stage Haste Creates Future Waste: Three Strategies that Integrate Your Value Story

    Early Stage Haste Creates Future Waste: Three Strategies that Integrate Your Value Story

    Integrating clinical and regulatory functions from an early stage adds value to your product, reduces costs and ultimately produces a sharper, more compelling value story.

    Read More
  • Three Ways To Thrive As Regulators Raise The Bar on Data Integrity Requirements

    Three Ways To Thrive As Regulators Raise The Bar on Data Integrity Requirements

    Take this three-pronged approach to detecting, preventing, and correcting data integrity lapses.

    Read More
  • Leveraging IDMP Compliance to Improve Your Data and Add Value to Your Business

    Leveraging IDMP Compliance to Improve Your Data and Add Value to Your Business

    A sound Identification of Medicinal Products (IDMP) compliance strategy confers business advantage as it results in high quality, harmonized data that can be queried efficiently.

    Read More
  • Want Faster And Cheaper With Higher Quality? Get It Right the First Time.

    Want Faster And Cheaper With Higher Quality? Get It Right the First Time.

    Weak or faulty quality systems can hurt a company at every stage of a product’s lifecycle. A structural commitment to data quality is the only clear route to achieve a competitive advantage.

    Read More
  • Beyond Compliance: Using Quality Metrics To Gain Competitive Advantage

    Beyond Compliance: Using Quality Metrics To Gain Competitive Advantage

    Smart companies realize that improving data systems and quality metrics is not simply a matter of compliance; it's about transforming their business.

    Read More
  • Faster Is The New Normal In Oncology Drug Development

    Faster Is The New Normal In Oncology Drug Development

    Learn five risk-mitigation strategies to produce data-rich trials, better teamwork and more regulatory interaction.

    Read More
  • Leveraging FDA's Accelerated Pathways For Market Advantage

    Leveraging FDA's Accelerated Pathways For Market Advantage

    Successfully leverage the FDA’s accelerated pathways to reach the market more quickly and enhance commercial prospects.

    Read More
  • Closing The Communication Gap Between Developers and the FDA

    Closing The Communication Gap Between Developers and the FDA

    To get the most out of pre-submission meetings and avoid misunderstandings follow this new framework.

    Read More
  • The Opportunity And Pitfalls of Seeking Early Scientific Advance In The EU

    The Opportunity And Pitfalls of Seeking Early Scientific Advance In The EU

    While the advantages of seeking and adhering to the advice given by the EMA are clear, there are also several possible drawbacks you can avoid with these key strategies.

    Read More
  • Bridging The Gap: Satisfying Payers In An Era of Expedited Regulatory Pathways

    Bridging The Gap: Satisfying Payers In An Era of Expedited Regulatory Pathways

    Ensure expedited regulatory approval effectively translates into reimbursement and patient access.

    Read More
  • loading
    Loading More...