Welcome to Kendle - What we do - Clinical Development

Clinical Development

Patient access/recruitment

Comprehensive listing of services

Clinical monitoring team

An experienced clinical monitoring team

Because we recognize the critical role timely and thorough communications play in your project’s success, we have developed a team-style project management structure. This structure ensures that your program is completed on time and within budget, no matter what its size, complexity, or where it is in the world.

Each dedicated project team is headed up by a project leader, who manages and coordinates the activities of a multifunctional team. This team – comprised of clinical research associates (CRAs), data managers, biostatisticians, medical writers, regulatory experts, etc. – reports directly to the project leader and has a high level of experience and expertise in conducting clinical trials.

For example, our CRAs have experience across major therapeutic areas and have gone through a rigorous, comprehensive training program. Many are also medically qualified. In Latin America approximately 40% of our CRAs have MD degrees and another 40% are pharmacists. In addition to site monitoring, Kendle CRAs work closely with the project leader to ensure that comprehensive planning, responsibility definition, communication plans and action steps are documented in detail.

Kendle clinical monitoring services

Investigator meetings/notebooks
Site identification and selection
Study document reviewing, collection and maintenance
Pre-study qualification visits
Initiation, monitoring and close-out visits
Site adequacy review
Site management
Query resolution

During the course of a study program, your project leader will keep you regularly informed about each of the critical project milestones, both with paper and electronic reporting. Our project leaders have true accountability for the efficient and timely management of project assessments, complete project implementation, and tracking and resolution of any project issues.

Each project leader receives comprehensive, standardized training in the use of our proprietary project management tools and tracking systems. Two of these components include TrialWatch™, our internal global project management system, and TrialWeb®, our web-based clinical study collaborative tool. TrialWeb® allows sponsor and Kendle project teams to view clinical study reports and other correspondence and information anytime, anywhere.

Click here to learn more about our TrialWare® family of proprietary technology tools.

Kendle project leaders are at the heart of delivery and always remain 100% committed to your clinical goals. And with their combination of expert, flexible and inspired management, you can rest assured that whatever challenging times lay ahead, the clinical development process will be accelerated in every possible way.

Kendle project leaders

Have true accountability for all aspects of the study
Are involved in every stage of the process from first proposal to study completion
Have a clear and unambiguous reporting line to senior management
Prepare a comprehensive project plan, reviewed and approved by you
Develop project-specific operating procedures
Offer deliverable specifications
Provide time and events scheduling
Develop a communication plan
Communicate regularly with you regarding study progress
Implement regular communication and monitoring to ensure that all operating units at Kendle understand study timelines, budgets and deliverables
Identify training requirements
Develop/coordinate project-specific training materials/sessions (initial and continuing), as necessary
Manage vendors (for example, drug supply, central labs, CRF printing, etc.)
Employ a proactive approach to identify any issues, internal or external to Kendle, that may negatively impact any project milestone or deliverable, then develop and implement an appropriate corrective action plan

Partners in practice

When a pharmaceutical company came to Kendle with a request to run an entire program in the therapeutic area of inflammation, we set up a team to provide the full range of clinical development services. With more than 14,000 patients in North America and Europe, the main problem was how to achieve speed, while maintaining the highest level of quality.

Weekly team meetings allowed for continuous planning and updates to the project plan, providing each team member with a solid understanding of the milestones to be accomplished and the aggressive timeline associated with each.

This project management structure ensured rapid study execution. In one especially critical study, 96 of 120 sites received IRB approval in only 14 days. Site contracts were finalized within the same 14 days, some being completed in as little as three days. As for data management, CRFs for the entire program were, on average, scanned and indexed within 24 hours of receipt; databases were updated within 48 hours of query return; and the fastest database locks from date of last patient observation were a record-breaking 8, 10 and 12 days