Safety & Pharmacovigilance

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Leverage Our Expertise for Proactive Drug Safety Management and Pharmacovigilance

Patient Safety and well-being is one of the most important priorities of every pharma company. Techsol provides advanced business process solutions to manage Drug Safety throughout the product lifecycle. We follow stringent, regulatory compliant Pharmacovigilance procedures to monitor and manage the safety profile of any medicine with effective risk management and informed decision making.

With our presence across the globe our global pharmacovigilance team is capable of handling large case volumes, complex multi-center and multi-national safety operations with a combination of offshore and onshore teams. We offer independent PV Services or integrated with global medical information and regulatory services.

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Services We Offer

With Patient safety as the highest priority for pharmaceutical and biotechnology companies, the pharmacovigilance (PV) team has the crucial responsibility to identify, collect, and process the Individual Case Safety Reports (ICSRs) with confidentiality and report to regulatory authorities within the stipulated timelines.

Techsol has more than a decade experience in case processing and regulatory reporting services. With our combination of powerful technology and functional capabilities, we deliver high-quality functional services using our readily available validated AccelSafety database.

Our Case Processing & Regulatory Reporting Services:

  • Receipt and triage of initial and follow-up cases SAEs, AESIs, SUSARs, ICSRs, regulatory cases
  • Data entry
  • MedDRA coding
  • Narrative production
  • Analysis of Similar Events
  • 100% case quality control (QC)
  • Medical assessment
  • Case closure and locking
  • Generation and distribution of follow-up queries
  • Global expedited case reporting
  • EudraVigilance reporting using EV Web and E2B (R3) compliance
  • Reporting to Competent Authorities, Ethics Committees/Institutional Review Boards and Investigators
  • Reconciliation with external data collection partners (CROs, affiliates, partners, etc.)

With our innovative solutions such as Compier IRT with Mailbox, Compier ICSR QA and Compier L2A Case Management, we not only provide the process expertise but also use the best of technology to add value to clients.

According to GVP Module VI, every Marketing Authorization Holder (MAH) should have a dedicated Literature Monitoring program as part of safety monitoring of medicinal products to regularly search for articles in the literature databases and report adverse events. Non-compliance to this requirement may result in challenges like missing relevant ICSRs, inadequate aggregate reporting, missing safety signals and a major audit finding leading to withdrawal of the drug from the market.

Techsol’s expert PV Team can support you with Literature Screening and Monitoring to ensure that your Pharmacovigilance (PV) program adheres to the global regulatory requirements. With our proprietary Compier Literature Screening module, we offer clients an AI based Literature Screening with Duplicate Check module and that can seamlessly integrate with Medline, Ovid, Embase and PubMed databases.

Our end-to-end Periodic Aggregate Safety Report services includes planning, time management, data request, writing, quality control, communication and evaluation which is delivered by our experts who analyze and prepare the following:

  • Periodic Safety Update Reports (PSURs)
  • Periodic Benefit-Risk Evaluation Reports (PBRERs)
  • Development Safety Update Reports (DSURs)
  • Risk Management Plans (RMPs)

Additionally, we offer clients our Compier Aggregate Reports module that automates the complete regulatory reporting lifecycle management from pre-approval to post-approval of medicinal products with features like Digital Authoring, Collaborative Review and Insights & Analytics.

Safety signal management is an essential part of Pharmacovigilance and whole process of risk/benefit evaluation depends on the effectiveness of Signal Management, Detection & Analysis. Guideline on Good Pharmacovigilance Practice(GVP) Annex I – Definition defines Signal Management as “ A set of activities performed to determine whether, based on an examination of individual case safety reports, aggregated data from active surveillance systems or studies, scientific literature information or other data sources, there new risk associated with an active substance or a medical product or whether known risk have changed, as well as any related recommendation, decisions, communications and tracking.”

Techsol Signal Management, Detection & Analysis services are delivered according to the GVP: Module IX – Signal Management for products with pre- and post- authorisation.  We work according to the agreed and documented frequency, with a systematic cumulative review of data from all relevant sources to identify manage and analyses of potential new signal.

  • Global safety database listings and tabulations
  • Information from global literature screening(e.g. class effects, potential drug interactions etc.)
  • Emerging pre-clinical findings (e.g. teratogenic analysis, effects on pregnancy)
  • Blinded/open label clinical data (e.g. Data and Safety Monitoring Board (DSMB) summaries, clinical study reports, etc.)
  • Regulatory agency information [e.g.
    Pharmacovigilance Risk Assessment Committee
    (PRAC) findings, FDA notices]
  • Information from partners
  • EudraVigilanceData Analysis System (EVDAS) and
    information available from other regulatory databases
  • Competitor product labeling information

Techsol also offers authoring of Signal Detection reports of any new or on-going signals is documented in a report which is medically reviewed and findings assessed for impact on the benefit-risk profile. Additionally, the report may detail recommendations for confirmed signals or this can be discussed and documented via a safety review committee who are responsible for ratification of the findings of the signal detection and evaluation report.

The Safety Management Plan (SMP) is the key document that regulates all safety communication between the Sponsor and Contract Research Organization (CROs). As the key influencer to the execution of the clinical trial and drug safety activities, SMP consists of the respective roles, responsibilities, processes, and timelines for safety activities allocated between the Sponsor and the CRO(s). Also, SMP serves as a strategic document to ensure safety data during the clinical trial are accumulated and processed in a systematic manner.

Our team of experts designs robust planning that represents the key safety activities identified by the sponsor.   Creating the SMP document with Development Risk Management Plan, Safety Monitoring Plan, and other post-marketing safety documents. Techsol team works collaboratively to eliminate the compliance gaps, leveraging the technology and create efficiencies in managing your safety data.

RISK MANAGEMENT PLAN (EU AND GLOBAL RMP)

  • RMPs are considered as one of the foremost important regulatory safety documents and are legally binding to the license or marketing authorization holder.
  • At Techsol we understand the nitty-gritty of the overall risk management and diligently balance regulatory requirements vs speed and accuracy required during RMP authoring and updates.
  • Techsol can provide integrated epidemiology, programming, authoring, and medical review support for EU-RMP and Global RMP while working closely with clients’ teams for local RMP implementation.

AGGREGATE SAFETY REPORTS AND OTHER PV DELIVERABLES

  • PSUR/PBRER, DSUR, and other periodic aggregate reports are vital regulatory requirements covering the entire product life cycle and hence require functional expertise while creating them.
  • Techsol safety writers carry a deep understanding of aggregate reporting and also evolving safety profiles based on staged of the clinical development or use of safety data from marketing.
  • We can function as a bridge between your PV and MW team while liaising closely with regulatory, clinical and other stakeholders required for these multifaceted reports.

STANDALONE QC AND MEDICAL REVIEWS

  • Quality is the core of overall reporting with any of the regulatory agencies or writing for other audiences. Speed of authoring and multiple reviews may lead to inconsistencies or even incorrect data/messaging within documents which may lead to significant regulatory delays/denial or even can affect the reputation and credibility of the sponsor.
  • At Techsol, we believe in robust quality monitoring of all inhouse documents that we create for our clients and can also become an expert external QC agency for robust detailed medical or scientific reviews and data checks.
  • Owing to huge experience Techsol MW team handles QC of any document type at unprecedented speed with high accuracy and thus has become partners in success full submissions for may global organizations.
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PV audits are a systematic and independent examination to verify the suitability and efficacy of implementation and operation of a PV system, including its quality system.

Following the Good Pharmacovigilance Practice (GVP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP), audits make sure the trials and services are frequently conducted and controlled according to the quality standards.

Our global audit team with exposure and experiencing in supporting and being audited by global regulatory agencies, audits covering the whole PV system (case intake, adverse events processing and submission, project management, data management, QPPV role and responsibilities, aggregate report writing, signal and risk management, clinical safety, etc.).

With a more than a decade experience in working with global clients across USA, Canada, Japan, Europe and APAC, Techsol is preferred PV audit service provider for many large and small pharmaceutical companies. Conducting over 100+ remote and on-site audits, we have served and maintained long-term relation with 160+ clients.

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Techsol EudraVigilance services covers both drugs under development and marketed products and is underpinned by the EudraVigilance Medicinal Product Dictionary (XEVMPD) which contains details of all products under development or licensed within the EEA, which Sponsors and Marketing Authorisation Holders (MAHs) are required to maintain.

Techsol delivers following services to support your EudraVigilance system:

  • Support ongoing electronic reporting via EVWEB or EVPOST
  • Perform regular review for, downloaded Individual Case Safety Reports (ICSRs) submitted to EudraVigilance by regulatory authorities and other MAHs in accordance with centralised reporting requirements, and for (ICSRs) processed by the EMA Medical Literature Monitoring (MLM) service.
  • Manage the article 57 (XEVMPD) database for your products including submission of development and authorised medicinal product (DMP/AMP) information, PSMF location, MAH and QPPV contact details maintenance.
  • Monitor the EudraVigilance Data Analysis System (EVDAS) to the extent of MAH access and download electronic Reaction Monitoring Reports (eRMRs) and EVDAS line listing reports for use in the detection and evaluation of safety signals and benefit-risk analysis.
  • Manage the creation and maintenance of xml submissions of Annex I of the RMP via EudraLink portal
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According to the guidelines appointment of a European Union Qualified Person for Pharmacovigilance is mandatory requirement for all medical products authorized within the EU and they are responsible to ensure that the Marketing Authorization Holder’s PV system is compliant with EU requirements.

Techsol QPPV Services can support and oversee:

  • Establishing and maintaining the PV system in the EU. Promoting, maintaining, and improving compliance with the European legal requirements.
  • Review and approval of protocols of any Post-Authorization Safety Studies (PASS) conducted in the EU or pursuant to a RMP agreed in the EU, as well as maintaining awareness of any PASS requested by a Competent Authority (CA), including the results of such studies.
  • Maintaining awareness of risk minimization measures for the medicinal product covered by the PSMF and having sufficient authority over the content of Risk Management Plan (RMP).
  • Ensure conduct of pharmacovigilance and submission of all PV related documents in accordance with the legal requirements and Good Pharmacovigilance Practices (GVP), including the correctness and completeness of pharmacovigilance data submitted to the competent authorities and to the European Medicines Agency (EMA).
  • Oversee the safety profiles and any emerging safety concerns regarding the medical products as covered by the PSMF.
  • Maintaining awareness of any condition or obligation adopted as part of the marketing authorization and commitments related to safety of the safe use of the product.
  • Single Pharmacovigilance contact point for CA’s EMA and inspection on a 24/7.
  • Ensure full and prompt response to request from CA’s in Member States and from the EMA for the provision of information related to the safety and risk management of the medical products.
  • Supporting in the preparation of regulatory action in the EU in response to emerging safety concern.
Business Analysis

The Pharmacovigilance System Master File (PSMF) is a legal requirement for any medicinal product authorized in the European Union (EU). The PSMF provides a detailed description of the entire pharmacovigilance system for the organization and documents the performance and compliance with the requirements as described by Good Pharmacovigilance Practices (GVP).

Techsol follows GVP Module II’s recommendation for modular based PSMF:

  • Section I qualified person responsible for QPPV
  • Section II organizational structure of the MAH
  • Section III sources of safety data
  • Section IV computerized system and database
  • Section V Pharmacovigilance process
  • Section VI Pharmacovigilance system performance
  • Section VII quality system

We provide author, review or provide support in preparing a PSMF in preparation for product application/authorisation in the EU. If a PSMF is already in place, Techsol can provide support in of the PSMF, including review and update as required.

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