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Empowering Compliance, Ensuring Product Safety
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CASE MANAGEMENT
PharmXL delivers continuous adverse event management and reporting services around the clock, ensuring compliance with regulatory timelines. The processing of adverse event cases is conducted from diverse sources such as clinical trials, literature, spontaneous reports, marketing programs, call centers, health authorities, and various licensee parties within the pharmacovigilance database.
LITERATURE SEARCH
PharmXL provides extensive global adverse event literature screening services, encompassing periodic surveillance of relevant publications worldwide to detect potential Individual Case Safety Reports (ICSRs) in databases like PubMed and Embase, along with targeted local journals in each market where the product is distributed. The identification of ICSRs is followed by triage analysis, facilitating expedited or periodic reporting of literature-derived ICSRs. This process contributes significantly to identifying potential or emerging safety signals for inclusion in benefit-risk analysis and safety reports.
SIGNAL MANAGEMENT
We tailor our approach to meet client-specific needs in the signal management process, offering a systematic end-to-end solution. Our services encompass signal detection, validation, prioritization, assessment, recommendation for action, and the exchange of information. We direct our efforts towards examining aggregate data, analyzing individual case safety reports (ICSRs), and assessing emerging signals' impact on a product's risk-benefit profile. Employing a comprehensive approach to optimize signal detection and management activities, with efficiency without compromising quality.
RISK MANAGEMENT
We deliver tailored guidance and strategic planning on risk management, starting with thorough risk assessment and identification for products. Our collaborative approach involves developing tailored risk minimization plans based on identified risks. Proactively reviewing and monitoring products, we enhance patient safety by minimizing risk profiles. We create and manage the Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans (RMPs) to cater the requirement for risk management of your product with focus on ensuring comprehensive risk management activities that prioritize patient safety throughout the product lifecycle.
AGGREGATE REPORT
Our team of in-house specialists guarantees the creation and submission of territory-specific periodic reports, including Periodic Safety Update Report (PSUR)/ Periodic Benefit Risk Evaluation Report (PBRERs), Periodic Adverse Drug Experience Report (PADER/PAER) etc. to regulatory authorities within specified timelines, using both electronic and printed formats. Our committed healthcare team ensures the production of high-quality and consistent reports to enhance patient safety.
QPPV/LPPV
We offer outsourcing services tailored to the requirements of the Qualified Person Responsible for Pharmacovigilance (QPPV). This can vary from a few hours monthly with additional QPPV consulting hours to complete QPPV services encompassing a QPPV, deputy/local QPPV, and administrative support. The QPPV serves as the 24/7 contact point for competent authorities, including backup QPPV. Our QPPVs are skilled and highly experienced in maintaining and establishing pharmacovigilance systems, monitoring product safety, and ensuring compliance with audits and inspections. PharmXL also appoints the Local Person for Pharmacovigilance (LPPV) for seamless pharmacovigilance activities as countries legally require a LPPV at territory level who is required to communicate with local health regulatory authorities if QPPV does not reside in the territory.
PSMF
The Pharmacovigilance System Master File (PSMF) is a critical necessity for conducting pharmacovigilance tasks and must be maintained by marketing authorization holders. Its presence is mandatory during the submission of all new Marketing Authorization (MA) applications. We take charge of preparing and submitting the PSMF to the relevant authorities, adhering to applicable guidelines. Regular updates to the PSMF are conducted as needed, and these revisions undergo thorough review by the QPPV.
SAE and SUSARs
Our services encompass the entire spectrum of case processing for Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reactions (SUSAR) reports. This includes Triage, case registration, data entry, quality and medical review, culminating in the submission of reports to the respective regulatory authorities. Employing state-of-the-art drug/device safety databases and staying current with updated MedDRA and WHODD compiled according to relevant regulatory guidelines, we guarantee comprehensive and compliant services. Our dedicated experts are appointed to ensure both global and local reporting of SAE and SUSAR, with a commitment to timely reconciliation for effective safety data management.
SAFETY MANAGEMENT PLANNING
The Safety Management Plan (SMP) serves as a crucial procedure, mandating safety communication between the Sponsor and Contract Research Organizations (CROs). It aims to uphold the integrity of clinical study results and the reporting of serious adverse events to relevant authorities. At PharmXL, our expert team, boasting extensive global experience in clinical trials and research, adopts a proactive approach to pre- and post-clinical safety surveillance activities, ensuring patient safety throughout the drug development lifecycle. We collaborate with you to craft an SMP outlining key safety activities, encompassing a Development Risk Management Plan, Safety Monitoring Plan, and other post-marketing safety documents. This collaborative effort with the Sponsor team minimizes compliance gaps and enhances efficient data management.
DSUR and Ad-Hoc REPORTS
At PharmXL, our team of committed medical writers and experts ensures the timely preparation and submission of Development Safety Update Reports (DSURs) in periodic cycles or upon request. We prioritize providing responses to queries and preparing satisfactory descriptive Ad-Hoc reports promptly. Our dedicated approach to medical writing guarantees the quality and accuracy of DSURs, addressing regulatory requirements efficiently.
AUDITS
Our consultants bring extensive global experience to audit and develop systems for client companies, ensuring the effective implementation of pharmacovigilance (PV) activities. We conduct audits, mock audits, and inspections for our clients at headquarters, distributors, and other relevant bodies associated with the client's PV operations. Our team identifies shortcomings and findings during audits, providing management plans and advising on resolutions to harmonize PV systems.
TRAINING
Our experts are prominent PV trainers, educators, and lecturers specializing in updated regulatory aspects and global PV procedures. With experience as speakers in conferences, they offer role-specific training to pharmaceutical professionals through both offline and online modes for trainees' convenience. Training materials are exclusively designed to ensure comprehensive knowledge of PV operations, and assessments are conducted at the end of each training session.
STANDARD OPERATING PROCEDURES
PharmXL consultants contribute their expertise in crafting, implementing, and auditing SOPs across all areas of PV operations regulated by competent authorities. Clients receive both controlled and uncontrolled SOPs, with continuous tracking of significant changes and revisions throughout the periodic update cycle as well as Ad-hoc update.
SDEA MANAGEMENT
PharmXL specializes in crafting comprehensive Safety Data Exchange Agreements (SDEA) or Pharmacovigilance Agreements (PVA) tailored to your pharmaceutical landscape. Our experts ensures meticulous assessment and seamless collaboration to develop agreements that prioritize safety, compliance, and effective information exchange to safeguard your products throughout lifecycle. Elevate your safety data management with PharmXL.
GAP ANALYSIS
PharmXL provides versatile options, ranging from short-term tactical support to long-term strategic partnerships, starting with initial step of identifying the gaps in existing system and suggesting the customized solutions aligning with the organization's needs and strategy while ensuring the compliance of end-to-end pharmacovigilance activities. Whether addressing any emerging issues or outsourcing entire pharmacovigilance processes, our experienced experts stand ready to assist, regardless of the territory.