Efficient clinical trial management requires focus on many aspects at the same time.
- How are the sites performing?
- Is the trial progressing on time?
- Is the trial within budget?
- What are the anticipated risks?
- Have we covered the risks?
It requires a great team effort and expertise to ensure that the trial moves as per plan.
Our highly experienced Project Managers make sure that the progress of the trial is well planned. They have experience working with Monitoring Plans, Data Management Plan, Statistical Analysis Plans and Drug Safety Plans. The team is trained thoroughly to execute all these plans. Most importantly, the Project Managers are always prepared with a Risk Mitigation Plan for the myriad of possible roadblocks that occur during a trial.
Key Features of our Project Managers:
- Hands-on experience
- Therapeutic area experts
- Driven by Medical team to train and ensure compliance
- Risk Mitigation strategies in place
- Successful Track record of completing trials on time and within budget
PK Studies in patients
Phase I studies in patients pose special challenges like performing multiple blood draws in patients, sample handling, concomitant medications, adhering to various restrictions and even hospitalization as part of the study protocol.
Our research with healthy subjects has made us leader in Phase I. Being leaders in the conduct of early phase clinical studies brings a passion to our team and an easy understanding of the standard requirements for a successful Phase I study conduct in both patients and healthy normal subjects.
You can be assured that your project rests in the hands of a professional team who are experts at the conduct of PK studies. Our team performs close Monitoring of the sites, extensive training of sample handling and management, special observation visits to ensure the correct processes are in place at the sites and detailed manuals and charts for each activity allows the seamless conduct of the study.
Cliantha’s team has conducted many PK studies in patients successfully and more and more of our clinical trial sites have been successfully inspected by the FDA.