Services - oxygenclinicaltrial.com

Our services

Pre-Study

Ensuring that Investigators and Study Coordinators are trained on GCP, SOPs and study protocol;
Quick and efficient Clinical Study Start up with prompt "right first time" document completion process;
Rapid Contract negotiation and completion;
Timely and centralized regulatory submissions;
Generate study specific source documents, worksheets and study material development;
Site setup and study specific equipment placement to comply with protocol and ICH-GCP;
Chart review
Identify potential GCP-trained sites / Principal Investigators.
Provide GCP training to PI & study team on a regular basis. Provide GCP-trained Clinical Research coordinators for every site.
Identify and coordinate preparation & submission of essential documents to CRO/ Sponsor.
Site set up & essential document preparation.
Create a source document template if applicable.
Prepare site for Site Initiation Visit.
Pre-screening/ pre-identify cases for competitive trials Planning Recruitment Strategies.

During Study

Timely patient recruitment, enrolment, and retention.
Efficient data collection, timely data entry, and query resolution.
Document retention according to regulations and GCP/SOPs.
Investigator Site File maintenance.
Management of study supplies in compliance with the Protocol.
IP receipt, secure storage, administration, accountability, and destruction.
Performance of study activities and procedures according to the Protocol.
Continuity of staff with minimal turnover.
Encouragement of active participation of Investigator in the study events.
Ongoing communication with Sponsor or CRO.
Provision of adequate space and tools for CRA on-site during monitoring visits.
Adequate research amenities on/off-site.
Investigator/staff ongoing training according to protocol amendments.
Centralized and site-specific advertising and media creation, placement, and metrics.
Assist the Investigator in the ICF process, screening, and enrollment.
Implement recruitment strategies.
Maintain source documents in guidance with the Investigator team.
Completion of CRF/eCRF within specified timelines.
Maintain and update Trial Master File.
Dispense investigational products and maintain drug storage and accountability as per the requirements.
Coordinate Central Lab logistics and sample flow..
Coordinate subject follow-up visits and prevent loss to follow-up.
Coordinate subject reimbursements.
Coordinate monitoring and audit visits.
Coordinate SAE reporting on time and maintain documentation.
Coordinate and maintain ethics committee documentation during the study.

Post Study

CTMS sites are committed to meeting database lock deadlines.
Final IP accountability and return in collaboration with CRA per protocol requirements.
Post-study patient follow-up per protocol (if applicable).
Final report to IRB, Sponsor, Health Canada, and FDA (if applicable).
Trials documentation archiving according to Regulation, ICH-GCP, and SOP.
Coordinate close-out visit.
Resolve data queries on time in coordination with Investigators.
Archival of Data.

Other Services:

Multilingual study coordinators/research RNs.
Mobile research RN services to enhance patient recruitment and retention by providing GCP-compliant services and conducting selected study visits at home or other convenient locations for patients (if approval is granted).
enrollment for Non-CTMS network sites in early and late phases of the enrollment period.
Site Management for Non-CTMS network sites.
Staff training to support investigators, staff, and trainees conducting clinical research, including advice, support, materials, and resources for all types of clinical research studies.
Orientation program for new clinical research staff, including a training manual and various educational and professional development opportunities.
Study team planning and placement/hiring.
Regulatory Submission Support (Site level) for Non-CTMS network sites to assist in preparing and submitting regulatory applications, ensuring compliance with all technical requirements for swift validation and review.
Operational Support for Non-CTMS network sites.
Independent Monitoring and audit/inspection preparation for Non-CTMS network sites.
Strategy and consultation for Non-CTMS network sites.

Our services

Ensuring that Investigators and Study Coordinators are trained on GCP, SOPs and study protocol;

Quick and efficient Clinical Study Start up with prompt "right first time" document completion process;

Rapid Contract negotiation and completion;

Timely and centralized regulatory submissions;

Generate study specific source documents, worksheets and study material development;

Site setup and study specific equipment placement to comply with protocol and ICH-GCP;

Chart review

Identify potential GCP-trained sites / Principal Investigators.

Provide GCP training to PI & study team on a regular basis. Provide GCP-trained Clinical Research coordinators for every site.

Identify and coordinate preparation & submission of essential documents to CRO/ Sponsor.

Site set up & essential document preparation.

Create a source document template if applicable.

Prepare site for Site Initiation Visit.

Pre-screening/ pre-identify cases for competitive trials Planning Recruitment Strategies.

Timely patient recruitment, enrolment, and retention.

Efficient data collection, timely data entry, and query resolution.

Document retention according to regulations and GCP/SOPs.

Investigator Site File maintenance.

Management of study supplies in compliance with the Protocol.

IP receipt, secure storage, administration, accountability, and destruction.

Performance of study activities and procedures according to the Protocol.

Continuity of staff with minimal turnover.

Encouragement of active participation of Investigator in the study events.

Ongoing communication with Sponsor or CRO.

Provision of adequate space and tools for CRA on-site during monitoring visits.

Adequate research amenities on/off-site.

Investigator/staff ongoing training according to protocol amendments.

Centralized and site-specific advertising and media creation, placement, and metrics.

Assist the Investigator in the ICF process, screening, and enrollment.

Implement recruitment strategies.

Maintain source documents in guidance with the Investigator team.

Completion of CRF/eCRF within specified timelines.

Maintain and update Trial Master File.

Dispense investigational products and maintain drug storage and accountability as per the requirements.

Coordinate Central Lab logistics and sample flow..

Coordinate subject follow-up visits and prevent loss to follow-up.

Coordinate subject reimbursements.

Coordinate monitoring and audit visits.

Coordinate SAE reporting on time and maintain documentation.

Coordinate and maintain ethics committee documentation during the study.

CTMS sites are committed to meeting database lock deadlines.

Final IP accountability and return in collaboration with CRA per protocol requirements.

Post-study patient follow-up per protocol (if applicable).

Final report to IRB, Sponsor, Health Canada, and FDA (if applicable).

Trials documentation archiving according to Regulation, ICH-GCP, and SOP.

Coordinate close-out visit.

Resolve data queries on time in coordination with Investigators.

Archival of Data.

Multilingual study coordinators/research RNs.

Mobile research RN services to enhance patient recruitment and retention by providing GCP-compliant services and conducting selected study visits at home or other convenient locations for patients (if approval is granted).

enrollment for Non-CTMS network sites in early and late phases of the enrollment period.

Site Management for Non-CTMS network sites.

Staff training to support investigators, staff, and trainees conducting clinical research, including advice, support, materials, and resources for all types of clinical research studies.

Orientation program for new clinical research staff, including a training manual and various educational and professional development opportunities.

Study team planning and placement/hiring.

Regulatory Submission Support (Site level) for Non-CTMS network sites to assist in preparing and submitting regulatory applications, ensuring compliance with all technical requirements for swift validation and review.

Operational Support for Non-CTMS network sites.

Independent Monitoring and audit/inspection preparation for Non-CTMS network sites.

Strategy and consultation for Non-CTMS network sites.

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