Global Pharma Tek
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| | |
| Global Pharma Tek | |
|---|---|
| Type | Private |
| Industry | Pharmaceuticals |
| Headquarters | 2025 Lincoln Highway,
Suite 225 Edison, New Jersey 08817, USA |
| Number of employees | 51-200 employees |
Contents
About
Global Pharma Tek is a fast-growing premier global pharmaceutical company that provides end-to-end services in pharmaceutical industry round the globe. Global Pharma Tek offers services like Drug Discovery, Clinical Trials, Drug Delivery, Regulatory and Intellectual Property Rights, Marketing and Strategic Human Resourcing. Global Pharma Tek is specialized in providing highly technical pharmaceutical and healthcare solutions and services in a cost effective way around the globe.
Global Pharma Tek enterprise-class clinical software and clinical functional services provider, offers unique blend of both clinical trial domain and core IT expertise with thorough understanding of healthcare and pharma industry and regulatory standards. Global Pharma Tek, clinical functional services practice (FSP) enable pharmaceutical and life sciences industry customers realize their vision of safe, effective, and FDA approved delivery of drug at the lowest cost and at the fastest time to market.
With core technology focus in the areas of statistical programming, business intelligence & data warehousing, enterprise application integration and enterprise architecture development, enterprise resource planning and custom applications development, along with clinical domain expertise, Global Pharma Tek offers a full range of specialized functional clinical & IT in-sourcing, IT projects development, clinical functional & IT projects outsourcing, software enabled services.
Company Mission
Achieve leadership in services offered through team work, cost consciousness and excellence in science & technology.
Company Vision
To contribute technically for the integrated drug development process and enhance the quality of pharmaceutical formulations by constantly innovating and creating an impact on healthcare industry.
Company Service
Pharmacovigilance
Global Pharma Tek is an emerging CRO giving end-to-end solutions in Pharmacovigilance. Company offer an extensive variety of services in Safety and Risk Management which includes state of the art call centers, case preparing and processing, wellbeing reports of individuals, total safety detailing reports, signal detection and risk administration and management, and counseling all in support of it's customers pre-advertise improvement and post-marketing exercises. The group of researchers, clinicians, and medicinal consultants masters in assessing risk and appraising risk. Applying imaginative advancements alongside its therapeutic mastery, Global Pharma Tek imparts a firm duty on quality for its worldwide customers and accomplices bringing about better, enhanced results in a cost-productive manner. Global pharmatek provide bellow mentioned services:
- ICSR Case Management
- Post-Marketing Reports
- Clinical Reports
- Medico-Legal, Literature, E2b reports
- Case triage and review
- Data entry and MedDRA coding
- Adverse Event Labeling
- Narrative writing
- Medical Review
- SAE reconciliations
- ICSRs and submissions
- Safety Database hosting
- Legacy case transfer
- 24/7 AE call center
- Medical Writing Services
- SAE Narratives for Clinical study reports
- Causality Assessments
- Analysis of Similar Events
- Aggregate periodic safety reporting (PADER, PSUR/PBRER, ASR/DSUR)
- ICSR narratives
- Dear HCP letters
- Risk benifit assessment
- Guided Questionneries
- Signal Evalution Report
- Health Hazerd Evaluation
- Safety/IT Enabled Services
- Literature Search and Review
- Signal Surveillance Activities
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Device Vigilance
Global PharmaTek provides a wide range of Device Vigilance services. We offer both clinical and post-authorization support. We are specialized in CE-marked, non-CE marked, Implantable, In Vitro Diagnostic Medical Devices and drug-device combination products in compliance with both EU MEDDEV guidance and FDA 21 CFR 803 and 812 standards.
Our services include:
- Collection and evaluation of incidents
- Adverse Device Effect (ADE) / Medical Device Incident (MDI) Case Processing
- Reporting incidents
- Detection and reporting of trends
- Field Safety Corrective Actions (FSCAs)
- Literature Search & Review
- Vigilance Quality Assurance
- Signal Detection & Evaluation
- Device Vigilance Reports Preparation & Submission
- ADE and MDI Reconciliation
- Field Safety Notices (FSNs)
- Periodic reporting
Medical Writing
Clinical Operations
Regulatory Affairs
Intellectual Property
Healthcare IT
Consulting
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