VCRO’s direct access to patient data from partner hospitals facilitates rapid patient screening and enrollment, ensuring timely trial completion, a cornerstone of clinical trial success.

• Deeply Rooted Expertise: VCRO excels across Taiwan’s clinical trial domains.
• Comprehensive Trial Investigator Database: We maintain a comprehensive database of trial investigators in all specialties.
• Expert Matching: We connect clients efficiently with suitable investigators and sites.
• Feasibility Assessments and Investigator Qualifications: We assess feasibility and verify investigator qualifications for compliance.

Ensuring clinical trial expenses align with contractual terms.

• Expert negotiation of clinical trial site agreements
• Comprehensive budget planning, tracking, and reporting
• Rigorous expense management and reconciliation

Prepare clinical trial sites for patient enrollment.

• Harmonize communication and coordination across trial sites.
• Prepare for clinical trial case initiation.
• Train trial personnel.
• Create comprehensive clinical trial documentation.
• Ensure complete trial operational documents and timely availability of trial materials and medications.

Serve as the primary point of contact for trial site personnel.

• Assist with subject recruitment and enrollment.
• Coordinate and monitor subject enrollment progress.
• Oversee and report deviation events.
• Manage serious adverse event (SAE) reporting.
• Provide timely support for trial execution at the site.
• Facilitate communication and problem-solving across multiple sites.

• Ensure regulatory compliance of IP packaging and labeling.
• Coordinate IP shipping and delivery.
• Facilitate import/export procedures.
• Monitor inventory and storage conditions.
• Reconcile IP quantities to maintain accountability.

Clinical trial monitoring is paramount for ensuring data integrity and ethical compliance in GCP trials.

• Rigorous source data verification (SDV) by trained CRAs to ensure GCP compliance.
• Detailed reports thoroughly documenting all findings, discrepancies, and follow-up issues identified during trial monitoring. These reports encompass a wide range of aspects, including ICF status, IP management, protocol compliance, adverse events, CRF status, and more.

Achieving consensus and consistency in clinical trial execution and criteria judgment.

• Investigator meetings for multicenter clinical trials held before or after trial initiation.
• Facilitate communication and coordination among investigators within and between trial centers.

• Streamlined document preparation and management: Efficiently prepare, manage, and archive all clinical trial documents.
• Time-based and document type classification: Organize documents based on time and document type to ensure timely, complete, accurate, and secure archiving of essential information throughout the entire clinical trial process.
• Comprehensive coverage: Encompasses all phases of the clinical trial, from document preparation and submission to trial preparation, initiation, execution, and completion.

Empowering Data and Safety Monitoring Boards (DSMB) for maximum subject protection.

• Prioritize subject safety by meticulously preparing and analyzing biochemical and laboratory data changes throughout the trial.
• Comprehensive analysis and evaluation of adverse events and protocol deviation data.

• When notified of a serious adverse event (SAE), CRA and safety officer (SO) collaborate closely with trial site personnel to monitor all aspects, including subject condition, actions taken, drug causality, outcomes, and follow-up.
• CRA and SO will also ensure timely and complete reporting of all SAEs to the relevant regulatory authority.

• In addition to CRAs’ monitoring, experienced CRMs co-monitor trial data to enhance oversight and ensure data quality and trial integrity.

We guide trial sites through regulatory inspections with expertise, composure, and extensive experience.

• Pre-inspection data and document verification
• Thorough understanding of trial execution
• Comprehensive inspection document preparation

Bringing our clients’ clinical trials to a resounding conclusion.

• Finalize trial expense settlements
• Ensure proper document storage
• Oversee proper disposal of trial materials, specimens, and medications