The early stages of clinical drug development are crucial as they cultivate decades of research and provide early data to demonstrate a product’s clinical effect and tolerance in patients. This is a crucial part of successful drug development. Every pharmaceutical product is different, and its clinical drug development process is also different. Indeed, this requires comprehensive support and expertise to ensure compliance with early phase clinical drug development to ensure that safety & efficacy data from early clinical stages is communicated clearly.

Pre Clinical/Early Phase Clinical Drug Development

It is important to have robust clinical regulatory strategies in place keeping in mind clinical outcomes that bring about new information on a product’s safety & efficacy. This also helps in determining the best approval pathway for clinical development. Communication with regulatory authorities for advisory meetings is imperative in order to obtain scientific advice wherever possible to develop comprehensive drug development strategies.

Drug development companies often face challenges when trying to translate pre-clinical/non-clinical data to help justify their clinical studies. Therefore, pre-clinical support is required to support these companies in managing the intricacies and complexities associated with the translation of this data to clinicals stages. Each company has their unique requirements for pre-clinical and early-stage clinical development needs; they require attention to their clinical milestones and overall end goals to help develop a clinical development program that would guarantee regulatory approval. Furthermore, clinical trial protocols and clinical trial synopses must also be developed based on current best practices and clinical insight aligning with regulatory requirements, including incorporating innovative program design to support various aspects of Phase II & III clinical trials as well as the safety evaluation plans for certain adverse events. A multidisciplinary outlook is required to integrated pharmacology & toxicology data which would contribute towards the clinical strategy, study design, and conduct to facilitate clinical development.

Early Phase Clinical Development Services

In the realm of clinical development that sees ever-evolving clinical and regulatory landscapes, it is important to partner with experts that are well-versed with such dynamic environments, regulations, and have the appropriate industry experience allowing them to stay ahead of such changes. DDReg brings together its clinical and regulatory domain expertise to provide early phase clinical development services to its drug development companies. The clinical team at DDReg is equipped in being able to identify obstacles that may emerge during early phase clinical development.

DDReg’s Early Phase Clinical Development Portfolio includes:

Identifying applicable guidelines & regulations and translating them for development & submission of clinical trial strategies for regulated and emerging markets (i.e., for first-in-human studies, clinical development plans)

Clinical Medical Writing support for the development of early phase clinical development documents (i.e., investigator brochures, literature reviews, clinical study reports (CSRs), case report forms (CRFs), manuscripts, toxicological/non-clinical and clinical expert statements)

Qualifying third-party clinical entities & conducting cGCP audits to support clinical drug development and clinical trials (e.g., CRO, CMO/CDMO including technology transfers)

Determining applicable expedited pathways for clinical development including but not limited to fast-track designation, break-through therapy designation, accelerate approval, priority review designation.

Coordinating between customers & vendors, and regulatory agencies for scientific advice during early phase clinical drug development

Project management including acting as the POC between customer and DDReg to manage the clinical development program, identifying risks & providing corrective action plans.

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