Important points for Sponsors to have meaningful relations with Site
Sponsor can create of positive relationship with site and that from the onset itself. This may include study design decisions and execution decision that reduces operational hiccups, prevent protocol amendments and decreases burden in particular on site. To make efficient trials, sponsor should aim for building good relationships with investigators to collaborate. Although starting and then nurturing Sponsor Site relationship can be difficult assignment because of increased competition.
The important points to built meaningful relation with sites could be
- To keep hospital supplies and IP ready so that whenever there is any enrollment it should not be rejected because of hospital supplies and IP
- Training is important part of GCP, It gives to confidence of handling the project as per guidelines. But repeat trainings can be dangerous, so only those who lack in training should be given training on GCP, SOPs, Regulatory guidelines etc.
- One of the important binding between sponsor and PI is distribution of the funds. So, Once you have signed document of financing the research project, then milestone must be match and funds must be released on time to time basis.
- One of the possible causes of good relationship is to have minimum protocol amendments. Any alteration in protocol can be a tedious task so keep it as low as possible.
- Monitoring should be done as it rule out the protocol changes. The best way to do monitoring is to inform in advance of monitoring date and then CRA comes for monitoring. Site close out visit should also be informed and should be done very carefully so that data collected to accurate.
- Data analysis is crucial component of Clinical Trials. Entries must be checked in the software for their accuracy and correctness. Each entry must be correct and statistical analysis should be accurate.
By doing some of the above things sponsor and investigator can have a good relation for clinical trial.