Pharmacovigilance Consulting
Our experts possess years of experience and are well trained to find solutions to the complex challenges facing the Pharmacovigilance departments, in addressing the ever-changing global regulatory requirements.
Medical Writing Services
As a team that is well versed in ICH and other regulatory guidelines, we can offer our writing expertise to create high-quality scientific, Drug Safety and Pharmacovigilance documents.
Narrative Writing
The importance of a good narrative to describe a serious adverse event (SAE) cannot be over-emphasized. We cater to the client’s needs in delivering appropriately detailed and concise narratives. We provide an accurate account of events by incorporating the critical elements of a case and applying the proper medical concepts, clinical judgment, and writing skills.
We write narratives for single case reports, clinical study reports (CSRs), aggregate reports (DSURs, PADERs, PSURs, and PBRERs), and other regulatory documents.
Coding Projects
Services include: Coding of adverse events, medical history, concomitant medications, procedures, and investigations to ensure consistency within a program/study.
Aggregate Reports
The RXpert Vigilance team has an in-depth understanding of the Pharmacovigilance principles, regulatory guidelines, and medical concepts requisite for creating high quality aggregate reports, including but not limited to:
- Development Safety Update Reports (DSURs)
- Periodic Adverse Drug Experience Reports (PADERs)
- Periodic Safety Update Reports (PSURs)
- Periodic Benefit Risk Evaluation Reports (PBRERs)
Medical Review
The physician team at RXpert vigilance is well equipped to handle the medical review of individual case safety reports (ICSRs) from clinical trials and post-marketing. They have a sound knowledge of the global regulations for case processing and are well versed in Argus, ARISg and a few homegrown safety databases. The team’s experience with triaging, data entry, coding, quality control and medical review will enable them to finalize cases in a timely manner to meet the regulatory requirements.
Signal Detection
Signal detection is a vital component of the safety monitoring process in both clinical development and post marketing. We will regularly review the relevant safety data (SAEs, AEs, lab data – case reports and listings) from ongoing clinical development programs and marketed products, and inform the client of the key findings. The signal assessment and evaluation incorporates information from non-clinical studies, literature, epidemiology data and class effects.
Risk Management Activities
Management of risks related to the use of medicines is a critical issue for the regulators and the industry alike. We will compile Risk Management documents that describe the potential risks of a product in a scientific manner driven by data and regulations. Such documents include:
- Risk Management Plans (RMPs)
- Risk Evaluation and Mitigation Strategies (REMS)
- Risk Minimization Strategies
Literature Review
We will search and review literature reports for adverse events and identify case reports and other information that is pertinent to the safety profile of a drug.
Regulatory Inspection Preparedness
We are very fortunate to have in our ranks, a physician who has participated in major inspections conducted by both FDA and MHRA. His knowledge, expertise, thorough understanding of the inspection process, and tactful handling of inspector questions were instrumental in successful inspection outcomes and would be extremely useful in training individuals preparing for a major inspection. The importance and value of this pre-inspection activity cannot be overstated. Additionally, we can provide guidance and assist in the preparation of post-inspection Corrective and Preventive Actions (CAPAs).
Safety Data Exchange Agreements
Partnerships and alliances are commonplace in the pharmaceutical industry. It is a regulatory requirement to have in place a document that outlines the methods of exchange of data and safety information between two or more companies. We create clear and well-defined Safety Data Exchange Agreements (SDEAs) that specify the responsibilities for reporting of single cases and aggregate reports. We will communicate with each of the partners to ensure that the respective company policies and procedures are adhered to and spelled out in the agreement.
Ad-hoc Query Resolution
Regulatory agencies from all over the globe request product safety information from the manufacturers on a regular basis. The nature of the query and the extent of the response can stretch the resources of a PV department. This is where RXpert Vigilance can step in and provide responses in a timely manner. Our comprehensive responses will incorporate safety data from clinical trials and post-marketing, scientific literature, epidemiology and the product label.
Clinical Trial Support
In addition to writing narratives and risk management documents, we support clinical teams by providing the following services:
- Write Informed Consent Forms (ICFs)
- Monthly (or periodic) review of line listings of adverse events to identify trends and to determine seriousness assessment
- Medical and safety input regarding protocols and investigator brochures (IBs)