Expert Insights

Expert Insights

Anticipating Next Steps and Resources You’ll Need In Clinical Trial Data Submission

Anticipating Next Steps and Resources You’ll Need In Clinical Trial Data Submission
22 October 2019

It goes without saying that clinical trials are dynamic and sponsors must be able to roll with the changes. Consulting, integration, and submission work are natural extensions of Synteract’s client support whenever we provide full-service delivery for a study, and can also be contracted as standalone services.

Regardless of the phase of the study, biopharmaceutical companies should establish and maintain a long-term development plan for the treatment or compound with a target of an NDA, MAA, BLA or other marketing authorization application dossier submission. It’s never too early to start thinking about the submission process. In fact, early planning is advisable.

As they plan ahead for each phase, drug developers frequently uncover that it takes more people--with programming, analysis, and writing expertise--than may be available in-house. Additionally, regulatory guidance may be necessary, as teams may not have the most up-to-date knowledge on changes or be familiar with the agency with which they are filing. Or, perhaps, the drug developer has acquired a new company and treatment or data structure was not the main priority in the early, exploratory stages of the trial, and now it is.

How can sponsors better anticipate and plan for the resources they will need as early in advance as possible? What might be given to a third party to provide muscle to get to deadline?

The best time to anticipate the questions is in the early stages of development when a consulting partner can contribute additional resources to the execution of those plans.

Discover what questions you need to be asking in each phase of the clinical trial. Get this clinical trial checklist from our very own SVP Global Operations, Mary Mattes, to proactively identify resources you will need for each phase.

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