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 | Monitoring Services » Medical And Other Scientific Services |
Protocol and Study Document Development:
At Max Neeman we have a dedicated team for development of:
- Trial protocol
- Other study related documents like case report form, patient's diary, etc.
- The protocol development team has representation from clinical research, statistics, and regulatory areas as well as includes therapeutic area experts.
Pharmacovigilance:
In trials managed by our team:
- Subject safety holds the highest priority.
- Round the clock coverage to receive SAE reporting will be available.
- Expert medical guidance will also be available if investigators wish to discuss any aspects regarding safety.
- Adequate process to meet safety reporting obligation towards Indian regulatory authority are in place and would be customized to sponsors safety-reporting requirements.
Medical Writing:
- We have qualified professionals from various disciplines proficient to carry out high quality medical writing.
- Our scientific and medical writers will be committed to ensure clarity and accuracy of all reports/manuscripts.
- If necessary we also consult expertise from the Industry to bring out excellent quality works.
GCP Training:
- Our team has the expertise to conduct ICH GCP training and workshops for clinical research professionals.
- Prior to initiating trials, we ensure that all investigators and site personnel are well trained in GCP and any training that is protocol specific.
Co-ordination of Investigator Meetings :
- An Investigator meeting coordinated by Max Neeman is geared toward creating a dynamic environment for the interaction of individuals with a common purpose.
- These interactive meetings are designed to be both informative and thought provoking and enable investigators to develop a dialogue with sponsors on best practices for gathering clinical trial data.
- The meetings also include training in key areas including trial protocol, current Good Clinical Practice and study-specific procedures.
- From scientific presentations to program management, meeting services, creative design and production, NMI aims to conduct meetings that are engaging, dynamic and effective.
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