Clinical Trial Challenges | Common Issues in Conduct of Clinical Trials

Getting Your Clinical Trial or Regulatory Submission Program Unstuck

No sponsor launches its clinical development program with the intention of adding or switching partners along the way. Clearly, it is much more efficient and cost-effective to have the same project team throughout. However, sometimes the progress on a program gets stuck or is going in the wrong direction. When that happens, we can help.

At Veristat we have a proven track record of getting clinical development programs back on track, we know the stakes are high and you can’t afford to slow down. Let us help you move forward.

How A Clinical Trial Gets Stuck

Clinical programs get stuck all the time, and many times, there is no one to blame. Sometimes the best intentions and decisions do not work out as planned. A few examples of common clinical trial challenges include:

Resources (subject matter/medical knowledge experts) are lacking or get pulled, and the work can no longer be done in-house
Internal teams, CROs, or partners fail to meet KPIs, milestones, or critical deadlines
Project teams (including internal departments/vendors) miscommunicate or misunderstand expectations
Protocols are poorly designed, misunderstood, or don’t accommodate real-life implementation situations
Sites, CROs, Labs, technology vendors, etc. are not trained properly on execution nuances

Reasons To Consider Help

It is time to consider help when you run into the following clinical trial challenges, such as:

	Trial Planning Regulatory Agency (e.g. FDA, EMA, etc) doesn’t concur with your protocol or development plan
	Study Start-Up Patient recruitment falls behind Site activation delays
	Trial Execution Quality issues with clinical trial data quality, study documentation, or deliverables KPIs or project milestones get missed
	Regulatory Concerns A Regulatory Agency performs audit and you must fix the audit findings FDA issues a Clinical Hold or Refusal to File

These are simply a few of many reasons to consider bringing on an external team to rescue parts or all of your clinical development program.

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