Understanding how regulatory strategy and operational procedures interact, our experts help identify any issues or roadblocks and make corrections to expedite the path to approval.
Clinical Trial Protocol Development
Our teams are continuously working with our clinical trial sponsors to find creative ways to improve both the speed and efficiency of their clinical development programs. We take a risk-based approach to assessing protocol design and complete a critical review of the data collection measures, volume and method, patient pathway, and expected outcomes.
We strive for quality delivery according to your timeline and will suggest alternative approaches based on a thorough landscape review and strategies to support optimal study outcomes.
Clinical Development Plan
The clinical development plan is a comprehensive document that outlines a holistic strategy for developing an investigational product, encompassing preclinical testing, clinical trials, regulatory submissions, and marketing authorization.
At Allucent, our unique combination of experts across multiple disciplines including biostatistics, clinical pharmacology, regulatory, and medical affairs enables us to be an optimal partner in authoring your clinical development plan and helping to ensure the success of your product development journey.
Digital Strategies in Protocol Development
The global clinical research environment is rapidly evolving, making it essential to explore a digital strategy for remote engagement and data collection for all protocols. We will review the key elements of your protocol, such as endpoint data collection methods, schedule of events, vendor data requirements, patient burden, engagement, and retention.
Decentralized Designs in Protocol Development
As part of the evaluation, our team will consider options for decentralized or hybrid design elements and make a recommendation in order to help guide you in making decisions that will boost the delivery of your clinical trial.
