Whitepapers and Articles

Driving by Data: A Faster, Better Road to Market

Prevent Costly Delays.

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.

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.

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.

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.

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.

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.

FDA's Accelerated Pathways Are The New Normal

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

Smart Strategies for the Beginning and End of Drug Development

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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