Publication Registration: |
Wednesday, March 23, 2022 |
Goods and Services Information
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Description:
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(1) - Biomedical, pharmaceutical, biotechnology and health-related research study services in the field of clinical trials of drugs, biologics, vaccines, health products, medical devices and other interventions to determine pharmacokinetics, pharmacodynamics, efficacy and safety namely: selection of trial sites and screening/enrolment of healthy volunteers and patients ('subjects/trial participants') in accordance with research design criteria; clinical project management, clinical trial management and clinical site managing and monitoring ('clinical operations'); monitoring trial participants for adverse reactions and preparation and presentation of reports of adverse reactions (pharmacovigilance); administration, management and providing medical and biostatistical support to clinical trial data and safety monitoring boards; administration of subject randomization and study product(s) supply management using clinical trial technologies (managing drug inventories); administration, collection, and management of study data; administration of other clinical trial technologies such as electronic patient reported outcomes (ePRO) data collection through mobile devices; clinical data management services and medical coding; analysis of study data including selection and application of statistical techniques and tests to study data; providing biostatistics and statistical programming; monitoring design and conduct of trials for compliance with applicable local and global regulations and policies and preparation and presentation of compliance reports; development and maintenance of internet websites for reporting on studies; medical writing, graphic design, and publishing of research study synopses, protocols, and clinical study reports; preparation of other reports of research studies and abstracts of reports, preparation and presentation of reports to study sponsors and regulatory authorities; regulatory strategies and regulatory agency submissions; act as subject matter experts (SME) to provide advice for any clinical trial and related services.
(2) - Biomedical, pharmaceutical, biotechnology and health-related research study services in the field of clinical trials of drugs, biologics, vaccines, health products, medical devices and other interventions to determine pharmacokinetics, pharmacodynamics, efficacy and safety namely: selection of trial sites and screening/enrolment of healthy volunteers and patients ('subjects/trial participants') in accordance with research design criteria; clinical project management, clinical trial management and clinical site managing and monitoring ('clinical operations'); monitoring trial participants for adverse reactions and preparation and presentation of reports of adverse reactions (pharmacovigilance); administration, management and providing medical and biostatistical support to clinical trial data and safety monitoring boards; administration of subject randomization and study product(s) supply management using clinical trial technologies (managing drug inventories); administration, collection, and management of study data; administration of other clinical trial technologies such as electronic patient reported outcomes (ePRO) data collection through mobile devices; clinical data management services and medical coding; analysis of study data including selection and application of statistical techniques and tests to study data; providing biostatistics and statistical programming; monitoring design and conduct of trials for compliance with applicable local and global regulations and policies and preparation and presentation of compliance reports; development and maintenance of internet websites for reporting on studies; medical writing, graphic design, and publishing of research study synopses, protocols, and clinical study reports; preparation of other reports of research studies and abstracts of reports, preparation and presentation of reports to study sponsors and regulatory authorities; regulatory strategies and regulatory agency submissions; act as subject matter experts (SME) to provide advice for any clinical trial and related services.
(3) - Biomedical, pharmaceutical, biotechnology and clinical research services in the field of clinical trials of drugs, biologics, vaccines, health products, medical devices and other interventions to determine pharmacokinetics, pharmacodynamics, efficacy and safety; selection of clinical trial sites and screening and enrolment of healthy volunteers and patients in accordance with research design criteria; clinical research project management and clinical trial management; monitoring trial participants for adverse reactions and preparation and presentation of reports of adverse reactions; data management and biostatistics related to clinical trials; management of subject randomization and study products supply management using clinical trial technologies; collection and statistical analysis of study data in the field of clinical trials and clinical research projects; management of other clinical trial technologies, namely, electronic patient reported outcomes data collection through mobile devices; monitoring design and conduct of trials for compliance with applicable local and global regulations and policies and preparation and presentation of compliance reports; development and maintenance of internet websites for reporting on studies for others; technical medical writing, graphic design, and publishing of research study synopses, protocols, and clinical study reports; consulting services for clinical trials.
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