• Includes case intake, triage, data entry, MedDRA coding, Narrative Writing, Making necessary follow ups.
• Quality Review for the cases processed.
• Medical review of the case including MedDRA coding and listedness review.
• Global regulatory submission/reporting.
• Generation of expedited and periodic reports line listings.
• Maintaining quality, accuracy, consistency and traceability which are the fundamentals of our standards.
• Compliance with regulatory timelines.
• Accountability.
• Covering all therapeutic areas.
• Maintaining and exceeding the latest industry standards including lean strategies.

• Compilation of periodic review of drug safety data/cumulative data.
• Cytelo covers all therapeutic area medications for preparation and submission of aggregate reports post marketing – Periodic adverse drug experience reports (PADER); Periodic safety update report (PSUR)/Periodic risk benefit evaluation report (PBRER)
• Covers premarketing reports - Annual report/Annual safety reports; Development safety update reports (DSUR) and clinical study reports.
• Expertise in preparation of Analysis of clinical overview (ACO).
• Consistency in report quality.
• In compliance with regulatory timelines.
• We have profound competence in preparing reports covering almost all Regulatory authorities globally.

Any new safety concern identified during drug safety monitoring process which is not specifically documented in pharma product label or for which frequency change is observed is considered as signal. An urgent safety restriction is a critical signal to be actioned immediately and information is provided to Regulatory authorities by the marketing authorisation holder (MAH). Any identified signal is assessed for its potential validity through quantitative and qualitative signal detection process and from available source evidence and conclude the signal as potential, risk and or refute. All confirmed signals are communicated to Regulatory authority by MAH as per appropriate timelines. Signals identified and confirmed by Regulatory authority or competent authority shall be analysed by MAH and provide appropriate justification.

RMP is to analyse, assess and optimize the pharma product benefit/risk balance. It is an ongoing activity designed to identify, characterize, minimize, and communicate product safety information. RMP shall be submitted for regulatory approval as part of its application process. The safety profile of the product shall be communicated to Regulatory authorities, Healthcare professionals, Patients etc., RMPs are updated whenever Competent authority is required, new significant alterations identified in benefit/risk balance of the product and during renewals. RMP is an obligation for the European Medicines Agency (EMEA). In the USA it is called as Risk Evaluation and Mitigation Strategy (REMS), designed to reinforce medication use behaviors and actions that support the safe use of that medication.

If you are considering a data migration, our experienced team can strategically guide you through the entire process. The pharmacovigilance safety data migration requires a standardized and decisive approach. Aspects such as data integrity, quality, security, and regulatory compliance must be thoroughly considered. Therefore, the planning of safety database migration to another system can sometimes become dismaying and stressful. At REFARph, we are expertise in Pharmacovigilance and safety management services. Pharmacovigilance data migration is one of the services we offer for pharmaceutical companies. We are fully capable of ensuring full spectrum PV support starting with data migration plan preparation until final case entry and further database maintenance.

Required new fields in the safety database or development of any patch for filling the gap in the safety database developed, tested for user acceptance test and it is deployed into test and production environment as appropriately. Required development, validation, UAT and deployment can be customized as per client requirements.

Medicinal or pharma product safety monitoring is performed after product approval through global literature and local literature monitoring utilizing literature search engines or through globally available software. The articles were analyzed for Individual case safety reports (ICSRs) validity. All valid ICSRs were databased and non-valid articles were analyzed for safety and efficacy during signal and aggregate report activity.

Individual case safety reports (ICSRs) are analyzed for seriousness based on seriousness criteria like fatal, life-threatening, hospitalization and or medically important adverse drug reactions. Global Regulatory reporting performed per country specific drug safety regulations and based on case level seriousness and listedness. Serious unlisted and non-serious ICSRs and clinical trial safety reports were reported diligently in due timelines to the Regulatory or Competent authority where the product is approved and marketed by Marketing authorization holder.