SAFETY MANAGEMENT
KlinEra is proficient of working on all major safety databases available in the market (Eg Oracle Argus Safety Database and ArisG Safety Database) and successfully assisted clients in reviewing and selecting system based on changed safety data requirements.
KlinEra has experienced staff who are trained on end to end case processing, safety risk management, literature search activities, regulatory intelligence services and signal management. Based on the Service level agreements (SLA), KlinEra safety team focuses on the below key performance indicators that ensures success in managing each project portfolio.
- Customer satisfaction
- Productivity
- Cost efficiency
- Turnaround Time (TAT)
- Return on investment (ROI)
- Alignment with goals of the organization
AEs (Adverse events) reports:
- We have the expertise to meet all requirements needed for AE/SAEs handling for cases arising from all sources.
- It includes interventional clinical trials, non-interventional studies and other solicited activities.
- We offer comprehensive management of cases, from receipt, data entry, coding, medical assessment, query resolutions and follow-up.
- While ensuring patient safety, regulatory compliance, quality and data integrity, the case reporting activities are completed within the timelines set forth by the applicable regulatory authority/ies on receipt of the AE/SAE report.
Case processing and reporting:
- Case processing is performed by qualified and highly trained pharmacovigilance staff.
- We offer resources who can perform Data entry, MedDRA coding, Narrative writing, drafting of Analysis of Similar Event, Medical assessment, 100% case quality control (QC), case closure and locking.
- We adapt to comprehensive internal procedures and use the best in class technology for safety information management by our validated comprehensive database.
Literature Review Specialist:
- Experts construct literature searches in such a way that it identifies both ICSRs of adverse reaction and relevant safety information.
- KE literature specialist team has 15 years of experience in global pharma, with a focus on literature.
Literature screening:
- KE provides local pharmacovigilance representatives who are required to perform the review of specific local non-indexed scientific and medical journals.
- KE local representatives can fulfill this requirement for the identification and processing of ICSRs and other relevant safety information.
Regulatory and Investigator site submission of ICSR’s, DSUR/PSUR and line listings:
- KE Safety team provides support for submission of CIOMS dossiers, DSUR/PSUR and line listings as per applicable regulatory guidelines and timelines to CDSCO and investigator sites and institutional review boards.
Signal Detection and Signal Management:
- Signal detection procedures on continuous and periodic signal detection & management are written in accordance with GVP: Module IX – Signal management for products both pre- and post-authorisation.
- KE undertakes the systematic cumulative review of data from all relevant sources to identify and evaluate potential new signals.
- Signal management process is based on the examination of individual case safety reports (ICSR), aggregate data from active surveillance systems or studies, and literature information or other data sources.
Aggregate Reporting:
- Periodic reporting of aggregate safety reports provides National competent authorities (NCAs) with comprehensive data of safety profile of drug.
- International standard for periodic reports follow reporting guidelines set by International Conference on Harmonization (ICH)
- DSURs, PSURs, PBRERs and PADERs: For products under development in interventional clinical trials, the aggregate report is the Development Safety Update Report (DSUR; ICH-E2F).
- For products with a marketing authorization, the Periodic Benefit-Risk Evaluation Report (PBRER), also commonly referred to as the Periodic Safety Update Report (PSUR), is used.
- Preparation and Submission of these reports include:
- Development and Maintenance.
- Planning.
- List generation from safety database.
- Preparation of line listings and tabulations.
- Drafting, medical review and formatting of reports.
- Submission of Reports.
- Management of assessment reports.
Medical Monitoring Expertise:
- In KlinEra, the clinical trial participants’ safety is the utmost concern and priority.
- Our in house highly qualified and experienced medical monitors ensure the safety and integrity of the trial subjects throughout the trial, from the initial design of the study to the final close-out.
- KE Medical Monitors having experience in various therapeutic areas provides their medical expertise for study initiations and conduct as per protocol and applicable regulatory guidelines.
- KE Medical monitoring team reviews and confirms the eligibility of each study participant before enrollment.
- The team monitors, analyses and ensures all safety parameters on a daily basis with proactive communication with relevant stakeholder at regular intervals.
- Organises and provides trainings and study related updates to all relevant study team members to ensure efficient and successful conduct of each trial.
- The team has expertise in handling multiple trials and acts as the point of reference for study team members and investigative site.
- The team determines how to evaluate safety events within a clinical trial and provides their services 24/7.
- The team provides inputs in the drafting various important study related documents.
KE Medical Monitoring team has experience in assisting trials for the following indications:
- Gastroenterology
- Hepatology
- Rheumatology
- Endocrinology
- Oncology
- Dermatology
- Respiratory
- Vaccines
- Infections
- Nephrology
- Auto-Immune
- Neurology
- Pain Management
- Cardiology
- Diabetology
KlinEra Operational Expertise in Pharmacovigilance and Medical Monitoring:
USA:
- USA operations will be managed via San Jose, CA Head Quarter
- Office-based Drug Safety Managers (DSM), Drug Safety Associates (DSAs) and Workflow Managers.
UK:
- UK will be managed via our London office. QPPV Managers, Workflow Managers, Drug Safety Associates (DSAs) are based out of the UK office.
India:
- India operations are managed via Mumbai, India Branch office
- Office-based Drug Safety Managers (DSM), Data Entry Associates (DEAs), Drug Safety Associates (DSAs), Workflow Managers, Quality/Medical Reviewers, Medical Monitors, Scientists, Medical Writers
- Office based Regulatory and Quality Management staff
- Medical Writing, Medical Monitors, Scientists, Data Management, Biostatistics, and Safety Management for Global Clinical Trial is managed from Mumbai, India branch office.