Insights On Partnering

  1. Shifting The Approach: 4 Tactics For ICH E6(R3) Implementation 4/30/2024

    In addition to codifying some best practices, R3 recommends that sponsors adopt an approach to identifying and managing areas of risk to mitigate potential issues and enhance overall success.

  2. Building A High-Quality IND From Scratch With Strategic Gap Analysis 8/12/2025

    A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

  3. How To Choose The Right CRO For Your Clinical Trial 3/28/2025

    Selecting the right Contract Research Organization (CRO) is critical for the success of a clinical trial. This article outlines essential factors to consider during the selection process.

  4. Transforming Clinical Trial Sites With Research Study Rockstar 2/10/2025

    This innovative platform addresses prevalent pain points faced by trial coordinators by streamlining workflows, automating patient communication, and providing intuitive dashboards that simplify trial management.

  5. Quotient Sciences Capacity Update July 2025 7/29/2025

    Explore how expedited review pathways can be strategically used to accelerate development while mitigating CMC risks.

  6. Avoid The Wrecking Ball: Targeted Solutions For Struggling Trials 9/30/2025

    In this presentation, our expert panel introduces the concept of scaffolding — a targeted reinforcement strategy designed to strengthen trials from the inside out.

  7. Consider India For Your Next HCC International Trial 11/16/2023

    Assess the feasibility of India as a potential venue for HCC trials as well as its epidemiology, historical perceptions, and untapped potential for international clinical research opportunities.

  8. The Right CRO Is An Extension Of Your Brand: Here's Why It Matters 9/23/2025

    For sponsors eyeing Australia, CROs with deep local expertise unlock the region’s advantages and, coupled with a global outlook, can ensure your trial aligns with international regulatory expectations.

  9. The Founder Behind The Platform 7/1/2025

    Learn about the founding and mission of ClinAI, a groundbreaking platform that leverages automation and analytics to enhance vendor selection and management.

  10. Dermatology Drug Development: Key Takeaways From AAD 2025 3/24/2025

    The 2025 American Academy of Dermatology (AAD) Annual Meeting underscored pivotal advancements in dermatology drug development, highlighting the essential role of innovative dermatology CROs.