ISO 9001:2015   |   ISO 27001:2013

Clinical Development Planning & Strategic Guidance

Clinical Development Planning & Strategic Guidance

We assist with the clinical development of compounds in your pipeline from proof of concept (Phase 2) to market enhancement (Phase 4) studies across therapeutic areas. With years of pharmaceutical experience along with our global network of key opinion leaders, we ensure that your clinical development plans and pivotal studies are developed with a global submission target in mind, while allowing for the flexibility of local execution at the protocol level. We further assist our clients by identifying Key Opinion Leaders (KOLs) in the US, Europe, India and ROW.

We provide the following strategic inputs:
  • Feasibility assessment for global studies
  • Regulatory strategies for global study initiation and conduct
  • Clinical Development Plan (CDP) harmonization
  • Alignment of CDP with regulatory strategies
  • Protocol design and development
  • Protocol instrument selection
  • IRB/EC responses related to protocol design
  • Issue resolution and optimization of  regulatory intelligence
  • Due diligence monitoring via regulatory and clinical experts
  • Internal Implementation of data transparency regulation and guidelines including internal company processes and best practices
  • Evaluation and development of quality management systems

Regulatory Submission Support Based on Strong Science and Strength of Process. The difference is in the data!