Planning for Success: A Guide To Clinical Trial Development and Design

Clinical trials are the cornerstone of medical advancement, rigorously testing new treatments and therapies. But meticulous planning is paramount before the first participant is enrolled. During the crucial pre-trial phase, here is what we at BARL believe you should be considering:

Putting Together Your Roadmap

Clinical trial management encompasses the entire lifecycle of a trial, from initial conception to analysis of results. During the planning stages, this includes:

  • Defining the Research Question: What are you trying to achieve with this trial? Is it a new drug, a different treatment approach, or a diagnostic tool? Having a clear objective guides the entire process.
  • Trial Design: Here, the 4 phases of clinical trials come into play. Phase 1 focuses on safety in a small group, Phase 2 on efficacy in a larger group, Phase 3 compares the intervention to existing treatments, and Phase 4 monitors long-term effects and safety in a broader population. The chosen phase dictates recruitment criteria, trial duration, and data collection methods.
  • Regulatory Considerations: You will need to ensure your trial adheres to Current Good Manufacturing Practices (cGMP) as set forth by regulatory bodies. cGMP outlines the standards for manufacturing, packaging, and distributing pharmaceutical drugs for human use.

Clinical Supply Management: The Backbone of Your Trial

Clinical supply management refers to the planning, procurement, packaging, labeling, distribution, and accountability of investigational products (drugs, devices, etc.) used in a clinical trial. We believe these steps are essential to integrate supply management with successful planning:

  • Demand Forecasting: Early on, you will need to estimate the amount of investigational product needed throughout the trial. This considers the number of participants, dosage levels, and probability of trial duration extension.
  • Sourcing and Procurement: Identify qualified manufacturers who adhere to cGMP. Negotiate contracts and establish a reliable supply chain to avoid stockouts that could delay the trial.
  • Packaging and Labeling: Investigational products require specific packaging and labeling that complies with cGMP and trial protocols. This must be planned well in advance to avoid delays.
  • Distribution and Storage: Determine secure and temperature-controlled storage facilities for the investigational product. Establish a distribution network that ensures timely delivery to trial sites while maintaining product integrity.

Streamlining the Process with a Clinical Trial Management System (CTMS)

A CTMS is designed to manage all aspects of a clinical trial. It can be a valuable tool in the planning stages by:

  • Centralizing Communication: A CTMS fosters collaboration between researchers, sponsors, and clinical trial sites by providing a central platform for document sharing and communication.
  • Inventory Management: The system can track the investigational product inventory across all trial sites, minimizing the risk of stockouts and ensuring accurate data on product usage.
  • Compliance: CTMS features can help ensure adherence to cGMP regulations by tracking product labeling, storage conditions, and participant dosing history.

By integrating a well-defined clinical supply management plan into your overall clinical trial development, you can lay a strong foundation for a successful and efficient trial.

At BARL, we currently support over 90 clinical trials or projects in progress with 20 years of experience. We can help you plan for a successful trial with comparator and ancillary supply sourcing, equipment rental, packaging, and trial management software services. We can help you make your planning easier by identifying common pitfalls and guiding you to work with the right partners who can ensure your trial occurs with little delay. Contact us today to see how BARL can help kickstart your next clinical trial.

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