CAPABILITIES

CAPABILITIES

Our team consists of physicians with huge clinical experience who, in addition, are high level professionals in the field of pharmacovigilance, safety surveillance and risk management, signal detection, aggregate reports review, and ICSR. We are able of providing acme quality pharmacovigilance services to pharmaceutical companies to meet high regulatory requirements.

THE FULL RANGE OF OUR CAPABILITIES IS LISTED BELOW:

PRODUCT LITERATURE REVIEWS

Routine Literature Review for detection of Safety Signals

Ad hoc comprehensive Literature Review for designated safety signal as requested

Review, analyze and develop conclusions based on sound scientific and medical knowledge and with reference to the existing product label

Provision a summary report of the review to the client

CASE/CASE SERIES REVIEWS

Review, analyze, synthesize Individual Case Safety Report (ICSR) and narrative line listing data, and/or develop conclusions

AGGREGATE DATA REVIEW

Support signal evaluation and data review

Review of Argus© safety database including a detailed review of relevant individual records in support of signal evaluation

Provision of support to Health Authority (HA) safety queries, label updates, scheduled and ad-hoc safety reports/safety updates including signal validation/evaluation reports

Periodic case reviews in Empirica©

COMPREHENSIVE REVIEW OF PUBLISHED AND PRE-PUBLICATION LITERATURE RESOURCES

Review, assess, summarize relevant articles

Identify articles that require immediate escalation based on benefit/risk of the product, critical event, medical judgment

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Inform the client with a summary and conclusion of the article

Identify articles for inclusion in PSUR/PBRER – write summary for PSUR/PBRER

Identify, assess and summarize relevant articles based on pre-determined event of interest for the product

AD HOC LITERATURE SEARCHES

In collaboration with the client safety and library personnel, develop search strategy for ad hoc requests

Review and assess output; identify relevant articles, summarize and present results

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INDIVIDUAL CASE SAFETY REPORTS

Intake and Triage

Monitor the receipt of ICSR from the sponsor/client

Provide an acknowledgement (applicable for both initial and follow up information) on the receipt of ICSR as defined or as agreed or as per client expectation

Perform a meticulous and exhaustive duplicate search as per the defined work instruction to ensure no duplicate entries are made in the safety database

Notify the sponsor if the any report deemed to be a duplicate

Review the source document for valid case criteria, follow-up information and information adequacy

Request for follow-up information, if required

Case creation

Provide initial seriousness assessment for a case, categorizing the case type, assigning the case priority, coding events, product and relatedness information

Responsible for completing the Intake and Triage activities in safety database within the stipulated time

Update the assigned trackers

Work closely with case processor/Lead/Project Manager for daily operations

Data Entry (Case Processing)

Perform duplicate search as per the defined work instruction to ensure no duplicate entries are made in the safety database

Verify the initial data entry done at the triage step as per the inhouse/ client SOP’s/ guidelines to ensure the quality

Request for clarifications if information is not available/not adequate/not clear

MedDRA coding, medical history, events, laboratory details using the latest MedDRA version

Code product and concomitant medication details (WHODrug Global)

Perform labelling and causality assessment

Prepare a narrative as a stand-alone information covering all the relevant information pertaining to the case

Responsible for completing the case processing activities in safety database within the stipulated time

Ensure timely and appropriate regulatory submissions

Provide feedback to Triage person on the errors/ discrepancy noted

Update the assigned trackers

Participate in Process Improvement Initiatives to keep up the Quality and Compliance score

Medical Review

Perform medical review of non-serious, serious and potentially serious ICSR with emphases on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance

Perform triage of cases and determine seriousness and relatedness across products as assigned

Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling, review narrative

Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas

Involve in process improvement activities like implementation of quality control process

Provide medical guidance and expert opinion on the cases to the Data entry associates peer reviewers to help resolve queries

Identify and resolve case issues, coordinate with client therapeutic teams and within Functional TEAM MANAGEMENT AS APPROPRIATE

Maintain PV expertise, and understanding of international safety regulations and guidelines

Provide strategic and proactive safety input into development plans

Support due diligence activities and pharmacovigilance agreements

Responsible for completing the QR activities in safety database within the stipulated time

Provide feedback to case processors on the errors/ discrepancy noted

Ensure timely and appropriate regulatory submissions

Update the assigned trackers

Participate in Process Improvement Initiatives to keep up the Quality and Compliance score

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