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ElSahar
offers a broad array of services that
incorporate
the entire spectrum of clinical
development, from filing of
Investigational New Drug & similar
regulatory applications to product registration and post-marketing
studies on a global basis. Core services include:
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A
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Drug development and
regulatory strategy planning. |
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Phase I
(first-time-in-man) clinical trials. |
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Phase II, III &IV post
marketing clinical trials. |
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Feasibility study and
marketing analysis. |
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Preparation and submission of regulatory filings in Middle East,
Europe and USA. |
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Clinical study design,
protocol and CRF designing. |
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Investigators and
sites' selection from our International database. |
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Sites Activities:
assessment, monitoring, initiation and close out. |
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Study Sites
monitoring, and Audit preparation of the sites. |
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Data collection tracking
and assist with quires resolution. |
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Final study report
writing. |
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GCP and study protocol
training to the Investigators and Medical staff. |
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Arrangement of
clinical trials supplies. |
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Safety assessment and
reporting to regulatory authorities. |
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Clinical research and
pharmaceutical consultancy. |
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Medical research and
marketing feasibility studies. |
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Database for clinical
investigators and research sites. |
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Clinical project
management. |
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Medical translation for study protocol, CRF, written consent forms
and
clinical research study documents. |
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Study Meetings: organize agendas, take minutes and give
presentations
where required. |
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Feasibility studies for clinical research projects. |
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Clinical trials design, protocol writing, CRF design, queries
solving, safety &
QA, auditing, regulatory, registration, medical
translation, written
consent translation and design. |
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Investigator sites: select, initiate, monitor and close-down
investigator sites. |
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Maintain clinical
trial files. |
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Documentation: assist in the preparation/review of clinical trial
and
regulatory submission documentation and review and development
of
existing company SOPs and forms. |
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Clinical trials supplies: arrange and co-ordinate clinical trials
supplies (Drugs
and CRF), import and export license, dispatch,
return and reconciliation. |
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Set
up and tracing of regulatory and Independent ethics committee
approvals. |
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Co-ordination: liaise with investigator, sites, CROs, external
laboratories
and other contractors where necessary. |
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Study budget: assist in the maintenance of the study budget
including
tracking and authorization of payments. |
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Meetings: organize
agendas, take minutes and give presentations where required
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Data queries: track
and assist with resolution. |
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Analyses and
interpretation of clinical data (including establishment of
specification for listings and tables for clinical study reports). |
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Keep up-to-date with
relevant literature and regulatory requirements. |
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Prepare project plan,
operating procedures, study design, protocol, case
record form (CRF)
and written consent design. |
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Translation service
for Clinical research study documents accordingly with the
regulatory authorities requirements. |
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