To ensure the success of your clinical trial, it’s important to have an experienced, highly trained team that is capable of ensuring that quality data is consistently delivered. At VIETSTAR BIOMEDICAL RESEARCH, our clinical research associates (CRAs) are experienced in a number of therapeutic areas, including, but not limited to oncology, infectious disease, CNS and endocrinology. We have the expertise and training to effectively manage your clinical data.
HIGHLY QUALIFIED CLINICAL RESEARCH ASSOCIATES
Our CRAs are trained in ICH/GCP guidelines, as well as local regulations. Additionally, VIETSTAR BIOMEDICAL RESEARCH’s ongoing internal training program ensures that our CRAs are up to date on the latest industry trends and practices.
Over 90% of our clinical team members have medical & pharmaceutical backgrounds, enabling them to partner with clinical sites on the most complex trials. We look for CRAs with proven interpersonal skills who can mentor and work closely with clinical sites as well as VIETSTAR BIOMEDICAL RESEARCH’s functional teams.
At VIETSTAR BIOMEDICAL RESEARCH, we understand the importance of bringing safe, effective therapies to the market. As a company, we provide our CRAs with the tools to do their job — but it is the CRA who adds the care and attention to their job each and every day.
RISK-BASED CLINICAL MONITORING
Through electronic data capture (EDC) and remote clinical monitoring, VIETSTAR BIOMEDICAL RESEARCH can increase efficiency. As technology continues to evolve, there are many EDC platforms that provide our team the tools to monitor trends, upload key documents and query data entries between site monitoring visits.
At VIETSTAR BIOMEDICAL RESEARCH, we’re committed to quality, efficiency and effectiveness throughout the research process. As part of this commitment, we continue to look for ways to reduce costs and ensure quality data for our clients. With the right clinical site and selection of data review, as well as our comprehensive risk management tools and highly trained CRAs, VIETSTAR BIOMEDICAL RESEARCH’s risk-based clinical monitoring services may be the best choice for your upcoming trial.
VietStar Biomedical Research CRAs perform comprehensive site management and monitoring activities to include the following types of monitoring visits:
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Pre study qualification visits
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Initiation visits
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Interim monitoring visits
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Close out visits
All activities are performed in accordance with ICH- GCP and local ethical standards to ensure all investigational sites are compliant with all applicable regulations and protocol requirements.
VietStar Biomedical Research ensures ongoing site compliance via the continual ongoing review of the following:
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Site staff qualifications and experience
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Site staffing, facilities, storage and equipment
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Accessibility and eligibility of subjects
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Review and retrieval of regulatory documents
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Accurate and timely completion of all CRF and source data
In addition to on-site responsibilities each CRA is responsible for site management documentation and follow-up activities to ensure that site staff remains motivated and focused. These activities include the following:
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Site Visit Report and follow-up letters Review of safety reports
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Providing site training and support through communications
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Generation of status reports
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Maintenance of tracking tools/logs
VietStar Biomedical Research CRAs complete comprehensive site visit reports and follow-up letters which are provided to the VietStar Biomedical Research project management team within 10 working days of the visit; however, all urgent issues are immediately reported to project management. The visit reports provided by the CRAs include detailed action plans for all issues identified and all issues are tracked through to resolution.
VietStar Biomedical Research’s site management and monitoring procedures will be performed in accordance with ICH-GCP to ensure each investigative site’s compliance with regulations and protocol requirements, and to enhance expeditious enrollment of appropriate patients into the clinical study. Regulatory documents will be reviewed by the CRA on an ongoing basis during the study conduct phase, including verification of signed informed consent forms and investigator IRB notifications.
In addition, to ascertain that an identified investigational site is qualified to perform this study to VietStar Biomedical Research’s expectations, the CRA will review the following issues at the study site and report this “study profile” in a site visit report to VietStar Biomedical Research and Sponsor:
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Principal investigator qualifications and experience
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Site staffing, facilities, storage and equipment
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Adequacy of and accessibility to subject population
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Access to source documentation
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IRB and ethics committee issues
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Laboratory and pharmacy certifications and normal ranges (if applicable)
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Investigator agreement and indemnification issues
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Recommendations for investigational site approval or exclusion from the study
Site Initiation
Once all regulatory documents and approvals are received, a site initiation visit will be scheduled for those investigators who are unable to attend the investigators’ meeting. During this visit, the CRA will review the following with the principal investigator and his/her staff as appropriate:
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Study goals and obligations
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Investigator brochure
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Protocol procedures (with particular attention to inclusion/exclusion criteria, enrollment goals, adverse events, primary efficacy variables and GCP compliance)
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Informed consent procedure
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Randomization procedure
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AE/SAE reporting
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CRF completion and error correction/need for adequate source documentation
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Maintenance of the investigator binder and site visit log
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Laboratory sample handling procedures and results reporting procedures
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Clinical supply dispensation, accountability and storage procedures
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Any other issue as deemed important to the conduct of the study
Site Interims
The following issues are addressed at each interim visit as appropriate:
Informed consent
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Source document verification 100%
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CRF completion (may be done remotely)
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Expedient data retrieval and query resolution
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Drug accountability
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Check and review of the regulatory binder and its contents
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Clinical supply inventory
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SAE reporting
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Enrolment issues and targets
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Protocol amendments
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Significant protocol deviations
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Acceptability of facilities
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Personnel changes
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Updated regulatory documentation
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Laboratory sample handling
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Any other issue as deemed important to the conduct of the study
Following each monitoring visit, VietStar Biomedical Research will complete follow-up letters and site visit reports within 10 working days of the site visit date. These follow-up letters and monitoring reports will be forwarded to Sponsor on a monthly basis.
Preparation and submission of report on Serious Adverse Events
Reporting serious adverse effects to the sponsor and to the FDA, according to SOPs and FDA requirements
Preparation patient case narratives and SAE case narratives
Writing narrative descriptions of both significant and serious adverse effects for inclusion in the Final Study Reports.