Best Practices in Partnering on Clinical Trials Management

To ensure you get a quality process and accurate results in your clinical trials, your service provider needs to be cost-effective, strategic, organized and communicative.

Speed-to-market is everything when a company is developing a new medical device, drug or treatment.

Every day a new drug isn’t on the market has a significant cost to the drug’s developer. From drug discovery through the U.S. Food & Drug Administration (FDA) approval, developing a new medicine takes at least 10 years on average and costs an average of $2.6 billion, or $712,000 a day. Nevertheless, although the stakes are high, the rigorous course of clinical trials can’t be compromised.

To quickly ramp up resources for a new clinical trial and maximize ROI, pharma companies often look to a services provider that can provide support. When looking for a clinical trials services provider, pharma companies focus on five primary deliverables:

  • Price: Price is more than just the cost of services. Ensuring that the study is correct the first time and delivered on time reduces the potential for costly change orders that can cause budget overruns. Also, make sure you know what you’re getting for your money – are your vendors offering reasonable rates for the services they’re providing?
  • Strategy: Service providers need to present a solid, executable strategic on how they would conduct the study, reduce R&D timelines and exceed client expectations. Is your vendor presenting the strategy right upfront so you know it aligns with your goals? If you review the strategy even before the award is made, you know it will work for you through the bid defense, study duration and close-out.
  • Organization: Look for a dedicated project team that works collaboratively, rather than one that might be dispersed over a number of clients or operating in silos. The most effective team’s processes and procedures should also use Project Management Institute (PMI) standards as a baseline upon which project management and process excellence initiatives elevate the quality and ensure flawless study results.
  • Relationship: By prioritizing consistent and meticulous processes, your vendor should be able to easily communicate project status on a weekly basis via a comprehensive checklist. If tasks are not being completed as promised, this will allow you to ensure risk mitigation and quickly get back on track.
  • Talent retention: The attrition of specialized talent, especially in this tight labor market, can have disastrous results on the phases of a clinical trial. Ensure your vendor is adhering to a commitment to excellence leads team members to manage their workloads and have confidence in the quality of their work. If a vendor is delivering on price, strategy, organization and relationship, talent will reap the benefits of the positive and productive environment.
Only service providers that can satisfy these needs deserve consideration from clients. When clients see the value of a vendor’s participation and trust the quality, the vendor can begin to really make a difference. They can help reduce production time and costs for research and development and help pharma companies get to the market more quickly and at the highest possible quality.

In 2016, the pharmaceutical industry spent $157 billion on research and development, a figure predicted to grow to more than $180 billion by 2022. Clinical trial sponsors know what’s at stake and need a cross-functional partner that understands their needs. The most effective services provider will have not just the technical capabilities to get the work done, but the collaborative skills – a desire to ask the questions to determine the true needs and areas for support.

Want to learn more about what to look for in a clinical services provider? Contact Aerotek now.