White Papers

  1. The Golden Retriever Lifetime Study: 5 Years Of Progress In Veterinary Health And Biobanking

    This whitepaper is an overview of a prospective cohort study of approximately 3,000 Golden Retrievers under the age of 2 years at enrollment and how the extensive data and biological sample repositories will be used for future analyses of major diseases, disorders or conditions in Golden Retrievers.

  2. Defense In Depth: Off-Site Storage Of Biological Specimens And Biopharmaceuticals For Risk Mitigation

    Choosing an offsite storage facility means asking the right questions in order to determine if the storage provider has the appropriate risk mitigation infrastructure in place, beginning with a realistic threat assessment for the location.

  3. Cold Chain Qualification: 5 Questions You Must Ask When Shipping Biologics

    If you have asked and answered these five questions, and are using a rigorously designed and qualified shipping system, then the data will provide an objective affirmation that you performed due diligence and significantly advanced the commercial success of your product.

  4. 505 (b)(2) vs. ANDA: How Complex Drugs Fit In

    Read how recently released draft guidance documents can provide clarity on abbreviated approval pathways and highlight priorities of the FDA to increase competition in the marketplace with a focus on speeding generic approvals, including complex generic drug products.

  5. Pharma’s Digital Awakening: Research-Ready Health Information And AI To Reduce Cost And Deliver Better Treatments

    Digital innovations and their emerging technologies, such as artificial intelligence (AI), advanced analytics, and cloud-based computing, are transforming industries and markets across the world as they offer novel ways to boost R&D, increase product quality and safety, and ultimately improve customer satisfaction.

  6. Bringing Predictability And Optimization To The Contracting And Budgeting Process

    The clinical trials sector is awash in metrics, and while early ones generally made broad determinations, such as which sites are top enrollers, the trend is toward more precise metrics that are actionable and help predict where bottlenecks may occur. This is a radical change for stakeholders looking to resolve one of study startup’s most enduring challenges—improving budget and contract cycle times.

  7. How Disclosure As A Service Can Reduce The Burden And Raise The Bar For Transparency

    With the help of software and services, sponsors can expand their options. Sponsors struggling to maintain compliance can do so more efficiently. Those whose goal is to overachieve can turn such aspirations into reality.

  8. Could Adaptive Designs Be The Answer To Oncology Clinical Development Success?

    Across all therapeutic areas, clinical development faces well-documented, critical challenges that impact the pharmaceutical industry's ability to bring new medicines to patients – but in the oncology space, these issues are particularly acute. Read how adaptive trial designs can help address the challenges encountered in anti-cancer clinical development today by saving time, resources and improving the odds of success.

  9. Differentiating Oncology Research Pipeline In Today’s Competitive Era

    With novel therapies being launched there is a shift in data and evidence requirements as well. How can you be sure you are keeping up with the real-world evidence demands?

  10. The Model-Based Approach: A Better Way To Forecast Enrollment

    Compared to conventional approaches, a model-based approach to enrollment forecasting provides a more realistic assessment of the possible risks and outcomes for any given scenario, by accounting for the nonlinearity and randomness of real-life enrollment processes. In addition, a model-based approach offers many more advantages other than more realistic expectations.