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508-404-6379 | SFogelson@Develotron.com

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If you are looking to answer these types of questions, please contact Develotron. We will discuss our approach to finding the best possible answers based on your technology and your corporate objectives.

 
 

How can Develotron help with early-stage planning?

Even though our clients may be one or two years away from entering clinical trials, they will rely on our clinical development work to establish financial, manufacturing, regulatory, and non-clinical R&D decisions. We can help provide answers to the important drug development questions at any stage of the product's life-cycle.

What is the target indication and patient population for our product?
What is the expected clinical research time and cost for development in this indication?
Are there alternative development routes that will allow us to streamline the process?
How fast can we reach our corporate milestones?
What will my Phase I study look like, how long will it take, and how much will it cost?
How many subjects will I need to enroll?
How much drug will I need for my early phase trials?
What type of pre-clinical toxicity data will I need to enter clinical trials?
How do I make sure my protocol includes all the essential elements?
When do I need to write my first clinical protocol?
How do I meet and contract with key opinion leaders?
What type of SOPs will I need to enter clinical trials, even if key functions are outsourced?
What level of internal staffing is needed to manage early-phase studies?
How do I select a suitable CRO?
How do I make sure my CRO is giving me the best price and all the services I will require?

 
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