|
RESEARCH : |
|
| PROJECT MANAGEMENT |
| |
We undertake proper management of project by ensuring
- Prompt IEC submissions and follow up for timely acknowledgement and approvals
- Due completion of all document with proper soruce documents
- Proper filling of documents for easy accessibility at any time
- Total drug accountability
- Prompt documentation of adverse drug reactions.
- Speedy query resolution
- Recruitment of punctual participants and proper follow up visits along with proactively measures to minimize drop outs.
Efficient and timely co-ordination of all logistics involving courier dispatch of documentation. |
| |
| DOCUMENTS DESIGNING |
| |
Clinical trial needs various documents for various reasons like
- Ethics committee submission
- Regulatory submission
- Proper conduct of study
We under take design of various documents as per specifications of GCP guidelines. We also make sure that your study is designed as per GCP guideline and statistically sound.
This will ensure smooth ethenical clearance and proper conduct of study providing you with reliable output.
We undertake design of following documents
- Protocol
- Case record from
- Various study logs
- Information consent form
- Patient information sheet
- Investigator undertaking
|
| |
| INSTITUTION ETHICS COMMITTE |
| |
Our institution has a well-structure and registered institutional ethics committee for bio medical research on humans and a separate animal ethics committee.
The IEC provides prompt feedback within a specific time frame and meet s regularly. All IEC members are GCP trained and have experience in reviewing and discussing important aspects of the protocol, information consent form, etc, before providing their opinion
- SOP (available on request )
- Members list ( available on request
|
| |
| INVESTIGATOR IDENTIFICATION |
| |
 Proper identification of investigator is of prime importance to ensure proper and smooth conduct of the study.
Our institution has vast pool of investigators with specialists from diverse therapeutic area and a good patient population.
Beside this we also provider timely GCP training to al the investigators, which makes them most suitable for carrying out the study scientifically and ethically.
We all of the study to the most deserving specialist who can carryout the study successfully.
|
| |
GCP/ PROTOCOL SPECIFIC |
| |
Its in our policy to give GCP and protocol specific training to all the medical and paramedical staff involved in the study. Beside this we also prepare SOP for each and every procedure involved. Training is also given to involved staff members on all SOP”s.
This ensures error free conduct of the study.
All the training are imparted from experts in the respective field |
| |
| ADVANCED RECRUITMENT STRATEGIES |
| |
 Recruiting patients is an art in itself. It demands a fine balance between the ethical consideration of what is in the best interest of the patient and the needs of the study.
We employ various recruitment strategies, which ensure completion of target patient pool with maximum effectiveness and minimum dropouts. This could include activities such as camps and advertising if required. At the same time we make sure that recruitment procedure is within ethical guidelines and are approved by the ethics committee. |
| |
|
