Clinical Development Excellence
Strategic Consulting with Operational Focus
Our solutions enhance clinical development through:
- Protocol Optimization: Aligning protocols with regulatory and scientific goals to ensure compliance with clinical trial regulatory standards.
- Process Efficiency: Streamlining operations to cut costs and accelerate timelines for clinical trial data management.
- Patient Recruitment: Supporting the Sponsor/CRO with personalized expert recruitment plans and strategies to improve patient recruitment outcomes.
- Vendor Selection: Identifying top contract research organizations (CROs) and creating tech roadmaps to enhance collaboration.
- Quality & Risk Management: Integrating quality and risk throughout development to maintain high standards.
Specialized Change Management
Facilitating Effective Transitions
We guide organizations through:
- Site & Investigator Training: Ensuring compliance and operational readiness for clinical trials.
- Technology Adoption: Supporting effective EDC, CTMS, and RTSM implementation to optimize clinical trial strategy.
- M&A Integration: Harmonizing operations post-merger for seamless transitions.
- Regulatory Adaptation: Navigating changing regulations seamlessly to maintain compliance.
Recruitment & CRO Optimization
We address recruitment challenges and enhance CRO partnerships by:
- Developing strategies to attract top talent in the field.
- Streamlining CRO selection for better alignment with clinical trial goals.
Partner with us to drive sustainable impact in clinical development.
In today's complex landscape, even the most scientifically sound clinical trial strategy faces implementation hurdles:
· 45% of clinical trials experience significant delays due to poor adoption of new technologies and processes in clinical trial data management.
· 65% of strategic initiatives fail to meet objectives because of organi
In today's complex landscape, even the most scientifically sound clinical trial strategy faces implementation hurdles:
· 45% of clinical trials experience significant delays due to poor adoption of new technologies and processes in clinical trial data management.
· 65% of strategic initiatives fail to meet objectives because of organizational resistance, particularly in the context of clinical trial regulatory compliance.
· $1.1M average cost of a protocol amendment, often preventable with better change management and collaboration with a contract research organization.
We solve the critical gap between planning and execution, including effective patient recruitment strategies.
· Readiness assessments for clinical trial data management
· Communication strategy aligned with clinical trial regulatory requirements
· Training development to support an effective clinical trial strategy
· Sustainability planning in collaboration with a contract research organization for efficient patient recruitment
· Medical monitoring for clinical trial data management
· Program management in alignment with clinical trial strategy
· Performance metrics to ensure compliance with clinical trial regulatory standards
· Continuous improvement through effective patient recruitment and collaboration with contract research organizations