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Our
Services
When
partnering with us you will benefit:
Regulatory insight
Therapeutic area of expertise
Responsiveness and efficiency
Combined medical and technical
knowledge
Adaptive data management service
Extensive network
Broad operation field
Excellent quality system
Access to specific patient populations
PharmaEdge
Research offers everything
your company requires to organize, conduct
and complete successful clinical trials. Our
services include:
Single point of
contact for both in sourcing/ in-house and
outsourcing needs
Comprehensive global
site management (SMO)
Global clinical
trials management (CRO) services
Specific in-house
activities tailored to meet the sponsors
needs such as providing contract scientific
and QA personnel
Project management
Clinical supplies
logistics
Global customs
navigations
Global outsourcing
solutions
Providing secure
long-term storage of study drug
Insuring proper
protocol and informed consent translations
Providing detailed
bilingual laboratory manuals/specimens processing
instructions
Insuring proper
study-drug handling processes by designing
and supervising drug accountability tools,
such as bilingual pharmacy binders, drug
administration and drug storage instructions,
drug accountability logs, temperature logs
for both refrigerator and ambient drug storages
Designing bilingual
patient instructions, patient diaries, patient
questionnaires, patient/investigator assessment
tools
Insuring proper
on-site equipment such as centrifuges, specimen
and study drug refrigerators, and ability
to conduct blinded protocols such as secure
drug dispensing and storage areas, secure
fax machines, limited access to study drug
storage and dispensing areas
Principal investigators,
sub-investigators, study coordinators, laboratory
personnel training in all study procedures
such as informed consent process, assessments,
blood draws, medical photography, skin biopsies,
blinded assessors, study drug dispensation
and administration, patient teaching techniques
for study drug self-administration
Insuring accurate
and timely adverse events and concomitant
medications reporting by providing bilingual
adverse events and concomitant medications
logs
Insuring detailed
and accurate protocol deviations reporting
Assistance in initiation
meetings and close out visits
Preparation of
bilingual source documents and CRF templates
to insure meticulous protocol adherence
and accurate data transcription
Query resolution
assistance
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Innovative
Solutions & Intensive Support
The
team at PharmaEdge Research
fully understands
your unique challenges and we find innovative
solutions to meet those challenges. We deal
fully and promptly when resolving situations,
and we offer you all-encompassing support, including:
 Legal
Support
Selecting
investigative sites
Transportation
Support
Translation
of all research materials, reverse translations
Coordinating
activities of the investigators
Regulatory
Support
Approvals for Ethics Committees,
Ministry for Health Protection, Pharmacologic
Committees,
Import/Export permissions.
Finance
Support
Payments to administration
of
research centers, regulatory bodies, customs
authorities,
insurance companies, etc & hellip;
Logistics
Support
Certified and licensed
warehouses
for drug storage, specialized customs
brokers
Equipment
Support
Phone, fax, postal
services, internet
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