H&J CRO International
H&J CRO International, Inc., is a premier full service Clinical Research Organization (CRO) offering global clinical trial solutions. Established in 2003, and headquartered in the U.S. in New Jersey, also has five branch offices in China in Beijing, Shanghai, Guangshou, Wuhan, and Changdu.
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| | |
| H&J CRO International | |
|---|---|
| Type | Private |
| Industry | Pharmaceuticals |
| Founded | 2003 |
| Headquarters | New Jersey, U.S |
| Number of employees | 51-200 employees |
services
- Regulatory Affairs
- Medical Writing
- Data Management
- Electronic Data Capture
- Biostatistics
- Pharmacovigilance
- Clinical Trials
Pharmacovigilance (PV)
Our PV/Safety Team (Expertise, Quality, Compliance, Teamwork) We take pride in having a diverse, passionate and competent safety team. We are dedicated to provide the complete range of high-quality and competitive safety services for pharmaceutical, biotechnological, and healthcare companies. We offer a broad range of the active management of drug safety, risk management and patient health during the entire lifecycle of a product from first in human clinical trial through the conclusion of the marketing period of a product. Through in-depth and individualized consultations, we help our clients craft an efficient short, mid or long-term solution tailored to meet their needs.
Team Members
1) senior/junior safety physician
2) medical safety reviewer
3) safety scientist
4) medical scientific writer
5) safety system (database) expert
6) clinical database DM manager
7) SAS programmer
8) Pharmacoepidemiologist
9) ICSR data entry or QC manager (specializing in Argus, ARISg)
10) Safety manager of Quality, Standard and Training ( QST)
Expertise Covers
1) Medical review of individual case reports (e.g., AE, SAE, ESR, SUSAR); AE Case Entry (ICH E2B Standard), MedDRA Coding, WHO Drug Coding, narratives writing, query tracking, targeted follow-up
2) Aggregate Safety Reports：
1> Periodic safety update reports (e.g., PSUR, PADER, PBRER, ASR, DSUR, IND Annual Report, , Summary Bridging Report, Addendum)
2> Ad Hoc Safety Reports (e.g., Clinical overview/summary for labeling update , Safety expert report for assessment of safety queries)
3>Other reports (e.g., Medical impact analysis (MIA) reports, Safety summary, Customized line listings and summary tabulations for aggregate data)
3) Safety signal detection and data mining (e.g., MGPS), Labs, ECG, Holter Data Summary, development of targeted questionnaires for AEoSIs, integrated review of clinical trials data across protocols or programs, Pharmacoepidemiology review
4) Risk management planning and development (e.g., EU RMP, US REMS); risk data summary, risk minimization activities, ongoing evidence-based risk/benefit assessment, RMP related PV activities (PSUR, PBRER, CCDS/product labeling update, safety studies), overall assessment of benefit/risk balance
5) Development of company core safety documents (including DCSI, IB, CCDS) and local labels
6) Review and development of safety section in the clinical study reports; preparation of integrated clinical safety summary (e.g., SCS, ISS)
7) Development of safety related clinical trial documents (e.g., protocols, CSR, IB, CRF, ICF, SMP, MMP, SAE form)
8) Medical safety monitoring in Phase 1-4 clinical trials; ongoing safety data monitoring and assessment of potential new and unexpected safety signals
9) Strategic support and consultation for global new drug filings (e.g., NDA, MAA submissions)
10) Post-marketing PV activities including review of spontaneous case report and published literature, development of labeling update , database review, PV system update, preparation of PV audit and inspection, assessment and management of product quality issues and product recall/withdraw
11) PV medical safety assessment trainings, PV SOPs/ WIs/ templates development
12) Other safety-related activities: medical safety regulatory consulting services, Safety Data Exchange Agreement (SDEA) development, strategic planning in the development and growth of your safety departments, establish and manage medical safety related off-shore and outsourcing model and activities
Abbreviations of Related PV Terms (A to Z)
AE: Adverse Event
ASR: Annual Safety Report
CCDS: Company Core Data Sheet
CSR: Clinical Study Report
CRF: Case Report Form,
DSUR: Development Safety Update Report
ESR: Expedited Safety Report
IB: Investigator Brochure
ICF: Informed Consent Form
IND: Investigational New Drug
ISS: Integrated Summary of Safety
MAA: Market Authorization Application
MMP: Medical Monitoring Plan
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Verification history
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