Clinical Development
The Clinical Development practice helps clients maximize the efficiency and effectiveness of their clinical development organizations.
It’s a cliché, but it’s true: Clinical development organizations are being asked to do more with less. The clinical development process is complex, with many moving parts and potential challenges. We think the keys to a successful clinical organization are the right team, a sound strategy, efficient processes, and the right technologies. Our Clinical Development practice focuses on developing sound organizational strategy and optimizing operational efficiency. We help clinical organizations meet the demands of today and tomorrow.
Services:
Success in clinical development is key to the long-term success of pharmaceutical and biotech companies. Today, however, the size and complexity of clinical programs are increasing disproportionately faster than available resources. To succeed, clinical organizations must find new, more efficient ways of operating.
That requires reviewing (and often revamping) current work processes, organizational structures, and technologies. Our clients are clinical development leaders that are seeking a partner to help improve the efficiency and effectiveness of their operations. They need experts to help drive change initiatives so that their key staff can remain focused on producing clinical results.
Our Clinical Development Practice is composed of operations improvement specialists who are also experts in clinical development. We have the expertise to serve as an extension of our clients’ clinical development leadership teams and the focus to drive major change initiatives to completion as quickly as possible.
Our clinical development experts have seen numerous tools, processes, and methods for improving clinical efficiency through their work as consultants, as well as their previous experiences working in leading pharmaceutical companies, CROs, and other related organizations. As a result, they have developed a keen awareness of what actually works and what doesn’t.
The following outlines our Clinical Development Practice’s service offerings:
- Scaling for Growth
- Develop strategies to help emerging and midsize companies scale up their organizations to meet increasing demands
- Staffing Strategies
- Outsourcing Strategies
- Clinical Process Design and Improvement
- Protocol development
- Study start-up
- Study execution
- Study close-out
- New Technology Strategy
- Technology Selection, Implementation, and Integration
- Clinical trial management systems (CTMS)
- Electronic data capture (EDC) systems
- Outsourcing management systems
- Drug safety systems
- Process Development and Improvement
- CRO use and management
- Vendor identification and selection
- Vendor contract management
Feature Articles
Gary Tyson of our Clinical Development Practice discusses an approach for building and managing an environment of continuous improvement in clinical development organizations....
Tim Dietlin of our Clinical Development Practice discusses strategies for getting the most out of your EDC investment...
Spotlight
The protocol development process is broken. We can help fix it...
Sometimes, clinical EDC systems don't live up to expectations. Here's how to fix that ...