Trail Management and site management Services
The C clinical trials team provides a global platform. To meet the requirements of our clients,
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
Clindataceutics has a network of 100+ GCP trained Investigator sites. With our excellent rapport with Investigators and Key opinion leaders, we bring a high level of expertise into the execution of the studies.
Our site management services include identifying the best sites for the trial, helping the sites set up the required infrastructure for the studies, assisting them with resources as required and training the sites thoroughly.
Site Regulatory success
Clindataceutics works very collaboratively with the research sites prestudy, during study conduct and we support them post study including during regulatory interactions. Outlined below is a sample of the track records from FDA inspections of sites used for patient PK studies.