The Clinical Development team at Jenniss Research can lead your clinical program from the development of the clinical plan through completion of clinical studies. Our scientific knowledge, clinical expertise, and project management skills allow us to work with sponsors on many types of projects across a wide range of therapeutic areas. In addition, our project management team manages the timelines that ensure successful completion of key milestones.
The overall management of the study is the responsibility of the Jenniss Research Clinical Trial Manager (CTM). The CTM serves as the primary contact and is responsible for the conduct and oversight of the day-to-day operations for the study. The CTM works closely with the clinical team to address protocol questions and maintains close oversight of study-related processes and documents while adhering to study timelines.
We also provide clinical study monitoring from our highly experienced team of clinical research associates to ensure high-quality data and adherence to regulatory requirements.
Jenniss Research has an experienced group of statisticians that can provide comprehensive statistical services for all phases of clinical research and across multiple therapeutic areas. Our statisticians can provide input on the clinical development plan.
Communication Plan
The success of a study relies on clear, concise communication among all team members. The Jenniss Research CTM will serve as the central channel for communication between Jenniss Research and the sponsor and will maintain regular communication with the internal project team. Jenniss Research project status tools will serve as the primary source of project status information and will allow the CTM to report on all aspect of the study. The CTM will develop a Communication Plan for the study that outlines the routine communication systems and instruments among all parties involved in the study.
The outline of this plan includes, but is not limited to, the following:
- Key project team members’ roles and responsibilities
- Mechanism for communication (teleconferences, face-to-face meeting, electronic media
- Scheduled date and time, attendees, and key purpose for team conference calls and meetings
- Issue escalation within each organization with a schematic to demonstrate study team organization and hierarchy