SMO (Site Management Organization)
Since the purpose of clinical trials is to investigate the biological response of human subjects, SMO’s are required to comply with strict regulations and guidelines set by laws, exemplifying GCP (Good Clinical Practice). With complying with GCP, every clinical trial must secure the subjects' human rights and safety as well as guaranteed ethical and scientific justification.
Importance of SMO!
Help to ensure the conduct of the clinical trials are bound to ICH-GCP and India-GCP standards. The potential benefits of an SMO are: rapid and reliable patient recruitment, improved data quality and consistency, reduced study timelines primarily due to quicker study start-up, reduced site management time etc.
"A site management organization is not only a necessity for busy clinicians but also ensures quality data management." Says Dr. Kannan M. Narayana, chief operating officer, NarayanaNethralayaEyeHospital, Bangalore.
What we do?
Quest Scientific Research (Quest-SR) manages various duties derived from clinical trial implementation. We particularly assist medical institutions with performing various tasks throughout clinical trial processes. Quest-SR staffs are expertise in clinical trials so that clinical trial Investigators can fully rely upon them.
We coordinate and manage clinical trials by adhering to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) and all other applicable local, international GCP standards.
Staff Training and Support.
Compared to the pool of highly qualified physicians, the number of ICH-GCP trained investigators is very low. We help to alleviate this issue, by offering dedicated GCP training to our investigators and nurses. We have our own standard operating procedures and may put our investigators through a common, generic training programme as well as study-specific training.
How we assist Clinical Trials:
Two types of specific experts, named "Site Management Associate (SMA)" and the "Clinical Research Coordinator (CRC)" drive Quest –SR’s support workforce.
Site Management Associates (SMA’s)
As clinical trials are to investigate the biological response of human subjects, GCP states strict guidelines on performing duties related to document preparation and storage, as well as other administrative procedures and work practices.
SMAs assist with administrative responsibilities such as duties related to various contracts, filing of documents and records as well as responding to inquiries. They help ensure that the clinical trials meet the standards set by GCP while maintaining a seamless operation. As a consequence, they assist in improving the quality of the trials.
Clinical Research Coordinators.
CRCs act like doctors' partners rather than assistants, and proactively give support throughout the process. This includes selecting patients for clinical trial subjects, giving presentations on the procedure to patients, planning and managing the schedule for examinations and the administration of drugs, and collecting and managing various materials and data.
Despite importance, clinical trial implementation can be time-consuming and a considerable burden for doctors and staff in medical sites. CRCs help ensure that the clinical trials are performed seamlessly and minimize the stress placed on both the doctors and the patients.
Since the purpose of clinical trials is to investigate the biological response of human subjects, SMO’s are required to comply with strict regulations and guidelines set by laws, exemplifying GCP (Good Clinical Practice). With complying with GCP, every clinical trial must secure the subjects' human rights and safety as well as guaranteed ethical and scientific justification.
Importance of SMO!
Help to ensure the conduct of the clinical trials are bound to ICH-GCP and India-GCP standards. The potential benefits of an SMO are: rapid and reliable patient recruitment, improved data quality and consistency, reduced study timelines primarily due to quicker study start-up, reduced site management time etc.
"A site management organization is not only a necessity for busy clinicians but also ensures quality data management." Says Dr. Kannan M. Narayana, chief operating officer, NarayanaNethralayaEyeHospital, Bangalore.
What we do?
Quest Scientific Research (Quest-SR) manages various duties derived from clinical trial implementation. We particularly assist medical institutions with performing various tasks throughout clinical trial processes. Quest-SR staffs are expertise in clinical trials so that clinical trial Investigators can fully rely upon them.
We coordinate and manage clinical trials by adhering to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) and all other applicable local, international GCP standards.
Staff Training and Support.
Compared to the pool of highly qualified physicians, the number of ICH-GCP trained investigators is very low. We help to alleviate this issue, by offering dedicated GCP training to our investigators and nurses. We have our own standard operating procedures and may put our investigators through a common, generic training programme as well as study-specific training.
How we assist Clinical Trials:
Two types of specific experts, named "Site Management Associate (SMA)" and the "Clinical Research Coordinator (CRC)" drive Quest –SR’s support workforce.
Site Management Associates (SMA’s)
As clinical trials are to investigate the biological response of human subjects, GCP states strict guidelines on performing duties related to document preparation and storage, as well as other administrative procedures and work practices.
SMAs assist with administrative responsibilities such as duties related to various contracts, filing of documents and records as well as responding to inquiries. They help ensure that the clinical trials meet the standards set by GCP while maintaining a seamless operation. As a consequence, they assist in improving the quality of the trials.
Clinical Research Coordinators.
CRCs act like doctors' partners rather than assistants, and proactively give support throughout the process. This includes selecting patients for clinical trial subjects, giving presentations on the procedure to patients, planning and managing the schedule for examinations and the administration of drugs, and collecting and managing various materials and data.
Despite importance, clinical trial implementation can be time-consuming and a considerable burden for doctors and staff in medical sites. CRCs help ensure that the clinical trials are performed seamlessly and minimize the stress placed on both the doctors and the patients.
Let us discuss how we can help your organization.
Call (91) 481 2790666 or (91) 984 683099
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