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> Pharmaceutical Company
Challenges
Pharmaceutical companies are under increased scrutiny by regulatory agencies, media and consumers. Having a robust and responsive pharmacovigilance program in place is critical. Good corporate responsibility includes documenting and maintaining accurate, detailed records of adverse events; fulfilling complex and detailed reporting requirements; providing consistent and accurate drug information; managing product complaints; and hiring and training experienced, dedicated healthcare professionals.
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> Adverse Event Monitoring and Reporting
SYNCITIUM-INTERNATIONAL offers a pragmatic, systematic approach to adverse event monitoring that incorporates Good Pharmacovigilance Practices (GPvP).
SYNCITIUM-INTERNATIONAL’s professional healthcare staff is available 24/7 to receive calls from consumers and healthcare professionals and fully document all adverse event details as they occur. Our staff also pursues follow-up calls with appropriate due diligence to ensure complete and accurate information.
SYNCITIUM-INTERNATIONAL monitors promptly and accurately each adverse event that meet the criteria for expedited report to regulatory authorities (all death, life threatening, and serious/ unlisted/ associated cases) and prepares CIOMS-I reports.
SYNCITIUM INTERNATIONAL also prepares line listings and summary tabulations for Periodic Safety Update Reports (PSURs).
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> Drug Information Services
SYNCITIUM-INTERNATIONAL's Drug Information Service responds to inquiries from consumers, physicians, pharmacists and other healthcare professionals. Our staff is available 24/7 to provide callers with accurate information to assist safe, effective drug use.
SYNCITIUM_INTERNATIONAL manages many types of drug information inquiries including:
-Indications for use
-Contraindications for use
-Interactions
-Ingredients/excipients
-Dosage
-Mechanism of action
-Side effects
-Signs of overdose
-Storage/stability
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> The SYNCITIUM INTERNATIONAL Solution
SYNCITIUM-INTERNATIONAL provides a pharmacovigilance call center service to pharmaceutical companies with a complete post-marketing surveillance solution including adverse event monitoring and reporting; drug information services; and product complaint management. Our staff of experienced healthcare professionals, is specifically trained in pharmaceutical adverse event monitoring and drug information services. Our call center is equipped with state-of-the-art call center technology and the most current health and safety information resources available. At any time, our clients have access to the totality of the pharmacovigilance data and cases workflow via secured, dedicated intranet e-room.
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> Features
Single-source provider; offers complete outsource of adverse event, drug information and product complaint services
24/7 services; after-hours option available
Fees based on call volume; affordable to large and small
Services based on Good
Pharmacovigilance Practices
(GPvP) and Competent Authorities requirements
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> Product Complaint Services
SYNCITIUM-INTERNATIONAL can receive and document product complaint calls 24/7, or after hours as a complement to your own customer service department. Issues such as packaging, count and physical defects are documented and detailed PTC reports are provided to your Quality Assurance group. Our experienced staff will also identify AEs that may be embedded in product complaints and document them per protocol.
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