Best pharmacovigilance services

1

• CRO Company

www.globalpharmatek.com
2
Pharmacovigilance Services
Global PharmaTek is an emerging CRO giving
end-to-end solutions in Pharmacovigilance. We
offer an extensive variety of services in Safety
and Risk Management which includes state of the
art call centres, case preparing and processing,
well-being reports of individuals, total safety
detailing reports, signal detection and risk
administration and management, and counselling
all in support of our customers pre-advertise
improvement and post-marketing exercises.
www.globalpharmatek.com
3
Expert Team in Pharmacovigilance.
Our pharmacovigilance team is comprised of
industry professionals with deep experience in
both direct patient care and industry-specific
pharmacovigilance services, enabling us to
deliver safety data of the highest quality.
Working globally, Global PharmaTek can provide
integrated or standalone services to support
product safety monitoring in compliance with
regulatory requirements for safety surveillance
in pre and post-approval settings
www.globalpharmatek.com
4
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
www.globalpharmatek.com
5
Aggregate Reporting
PSURs/PBRERs and PADERs ASR, DSUR Signal
Detection Ad Hoc Reports Generation of
listings Integrated summaries of
safety Regulatory report submissions to
appropriate authorities Medication error and drug
abuse/misuse reporting
www.globalpharmatek.com
6
Safety/IT Enabled Services
Designing development of global safety data
repository, post migration integration of
safety data Implementation, validation,
maintenance upgrade of Argus applications Integr
ation of medical dictionaries to Argus
application Design, development submission of
regulatory, operational, analytical custom
reports Validated and up-to-date case processing
platform in a secure environment. Infrastructure
hosted on the cloud and maintained by Global
PharmaTek Training on Argus
www.globalpharmatek.com
7
Literature Search and Review
Literature searches Review of abstracts and
articles Full-text articles procurement and
translation Signal detection and analysis Adhoc
or customized literature searches to meet
specific needs
www.globalpharmatek.com
8
Signal Surveillance Activities
Ongoing medical review and analysis of
cases Aggregate analysis, including data
mining Meta-analysis of published safety
data Qualitative and statistical signal
detection Signal evaluation, assessment and
reporting Development of risk management and
communication plans
www.globalpharmatek.com
9
For More Information
Visit us _at_ http//www.globalpharmatek.com Write
us at info_at_globalpharmatek.com
Our Presence
USA 2025 Lincoln Highway, Suite 225 Edison, New
Jersey 08817, USA. Phone [phone]
INDIA Uptown Cyberabad Building, Block-A,
Plot-532 533, Sri Swamy Ayyappa Housing
Society, Madhapur, Hyderabad-500081, Telangana.
India Phone [phone]