GCP training & standardized SOPs
Our staff maintain up-to-date Good Clinical Practice (GCP) training, with recertification required every two years under WCR policy. Standardized SOPs and protocol-specific training support consistent study conduct.
Sponsors & CROs · Quality & compliance
Quality in daily practice. Accountability at every step.
Standardized procedures, trained teams, and documented follow-through support consistent study conduct, participant protection, and reliable data across our network.
- Participant protection
- Protocol-focused conduct
- Data integrity
A shared quality framework
Consistent practices.
Clear responsibilities.
We conduct studies in accordance with Good Clinical Practice (GCP), applicable regulatory requirements, IRB approvals and approved protocols. Shared controls support consistent execution, with responsibilities defined for the work at hand.
Consent & eligibility
Study teams use the applicable approved consent materials, allow time for questions and document the process. Clinical review checks eligibility against the protocol before enrollment.
Source & data integrity
Clear source records support the study data. Documentation review, query follow-up and traceable corrections help keep the record accurate, complete and understandable.
Document & version control
Protocol updates, study documents and training records need organized follow-through. Version tracking helps the team identify current materials and retain the relevant history.
Equipment readiness
Maintenance and calibration records support readiness for protocol-required procedures. Equipment requirements are reviewed with the clinical and operations teams.
Temperature oversight
Appropriate storage monitoring and documented excursion management support study materials. Potential excursions are reviewed and handled under the applicable study and site procedures.
Continuous quality improvement
Ongoing oversight.
Consistent follow-through.
We review study conduct, address quality concerns and refine our processes to support participant safety, protocol compliance and reliable data.
Follow-up identifiedCheck the training recordA completion record for the updated visit worksheet is missing from the study file.Assignment pendingBefore worksheet useAn open item enters the review.
Impact reviewAssess scope and priorityCheck whether training occurred and whether the worksheet has been used.Quality leadBefore worksheet useThe team reviews the potential impact.
Action assignedConfirm training and file the recordThe coordinator confirms completion and gathers the dated training record.Study coordinatorBefore worksheet useThe next step has an owner and a due point.
Action documentedConnect the record to the actionThe completion record is filed and the document checklist is updated.Study coordinatorReady for verificationSupporting evidence stays with the follow-up.
Verification in progressReview the supporting evidenceThe quality lead checks the record against the action before confirming closure.Quality leadVerification reviewCompletion is checked before the item closes.
Closure verifiedFollow-through completeThe reviewed record supports closure. Lessons learned inform ongoing quality improvements.Quality leadReviewed & completeVerified closure. Learning carried forward.
Quality concerns are addressed as they arise, with follow-up that supports consistent practices and continuous improvement.
Assess the impact
Review participant safety, protocol conduct and data integrity. Escalate concerns to the appropriate investigator, sponsor or IRB as required by the issue and applicable procedures.
Assign and document
Define the action, responsible role and due date. Keep deviation details, relevant communications and supporting records connected to the follow-up.
Verify and learn
Review the evidence before closure. Use root-cause review and corrective and preventive actions when appropriate, then check whether those actions address the problem.
Technology-supported document control
Current documents.
Prepared teams.
A document update can change more than a file. It can affect how a visit is performed, what a team member needs to learn and which records need to be retained.
Make the current version clear
Organize updates, effective versions and prior records so teams can identify the materials that apply to their work.
Connect changes with training
Review which roles and activities are affected, assign the necessary training and document completion.
Keep human review in the loop
Technology helps keep tasks and records visible. Investigators and study teams review the clinical and operational implications.
Update receivedDocument coordinationThe new version enters the review workflow.
Changes reviewedInvestigator & study teamThe team checks what changed and what it affects.
Training assignedStudy coordinatorRequired training is connected to the updated document.
Completion recordedStudy teamTraining completion and supporting records are checked.
Ready for useDocument coordinationThe current version is clear. The prior version stays in the history.
The purpose behind the process
People protected.
Records that hold together.
Quality controls have a practical purpose: support participant protection, reliable study conduct and data that can be understood and reviewed.
Protect the participant’s understanding
Consent is a conversation, with time to ask questions and consider participation. Clinical concerns are directed to the study team, and relevant changes are communicated through the appropriate study process.
Preserve a record that can be followed
Source documentation, study data, queries and corrections should tell a consistent story. Our approach emphasizes clear records, appropriate access and documented follow-up throughout study conduct.
For sponsors & CROs
A clear path from review to resolution.
We support on-site and remote monitoring with organized study documentation, coordination with the relevant team members and follow-through on findings. Questions and outstanding items stay connected to the people responsible for resolving them.
See our monitoring and operational capabilitiesOrganized documents for review
Relevant clinical and operational contacts
Documented findings and next actions
Follow-up through verified resolution