Pharmacovigilance

Pharmacovigilance

Pharmacovigilance

Nucleon Therapeutics is a leading global CRO providing end to end Pharmacovigilance & Medical Information services to generic pharmaceutical, biopharmaceutical, medical device, consumer product, and healthcare companies.  Our highly skilled and committed pharmacovigilance teams with in-depth subject matter expertise can produce high quality intellectual demanding pharmacovigilance activities. We make sure reporting obligations are in line with worldwide regulatory requirements and thus contribute to the ongoing risk-benefit assessment.

With a portfolio of services ranging from pre-clinical / clinical to post marketing we can promote patient safety together.

highlights-nucleon

Adverse Event Reporting

Our expertise lies in processing all types of adverse event reports

Clinical Trials

Our highly skilled team of data entry associate and pharmacists perform case processing for clinical trials and products under development cases. Their talent lies in shifting through large medical record data and extracting relevant information in the case as well as writing accurate medical narratives. The team also coordinates with the investigator and site for additional data requests and follow up information.

Post-Marketing

We handle all post-marketing case reporting right from spontaneous sources, solicited sources to social media sources.

Special Scenario Cases

All type special scenario cases are handled by our team including but not limited to legal cases, pregnancy cases, product quality complaints, etc. We also perform ad hoc reporting projects as requested by client including poison center control reporting and data migration projects.

Our Pharmacovigilance Services: ICSR safety - A choice you make

At NUCLEON, a team of enthusiastic and passionate physician and pharmacist with the many years of experience in various therapeutics areas providing full-fledged support across the single case processing including triage, MedDRA coding, medical reviewer, literature monitoring and quality check review.

Aggregate report writing

We ensure Aggregate reports and risk assessment document are created in the proper format with the appropriate clinical content and are submitted to the relevant regulatory authorities within compliant timelines.

We offer both, our qualified personnel and our processes ascertain detailed and correct presentation of particulars. Staff with hands-on experience in handling/managing standard and customized safety databases. And there is a dedicated team of medical writers and Drug Safety Officers (DSO) experienced in all therapeutic areas which works on standard TEMPLATE in accordance with ICH E2C (R2) compliance. Depending on the basis of contractual obligations, NUCLEON THERAPEUTICS takes part on the complete responsibilities for any medical or safety related issues.

Risk Management Plan

Sense and deal with problems in their smallest state

NUCLEON provides strategic advice and analysis; develops US risk evaluation and mitigation strategies (REMS) and REMS update reports; and compiles, writes and updates risk management plans (RMPs) for Europe.

We have extensive experience in writing complex Risk Management Plan (RMP),assessing risk benefit analysis, RMP maintenance, and in line with GVP Module V can advise or perform analysis of the effectiveness of the risk minimization activities for marketing authorization holders.

We provide organized and reasonable approach with the standard RMP TEMPLATE to identifying, assessing and managing risk. Effective and meaningful risk management, including assessment and handling of risks, needs experience, clear and sustainable principles. Based on the best information available we provide systematic and integrated structured solution to concise and complaint risk management planning and development, development of risk minimization, assessment of risk minimization and risk management studies to create value to the project.

PV System Master File (PSMF)

At NUCLEON THERAPEUTICS, quality management and compliance monitoring are attained to identify deficiencies in the overall approach to pharmacovigilance.The PSMF, the standard operating procedures and training derived from and the operational guidelines implementing the standard operating procedures form the cornerstone of all pharmacovigilance activities. The PSMF is a modular document containing all of the details of the pharmacovigilance system for the product used by the marketing authorization holder (MAH) with respect to one or more authorized medicinal products in order to ensure safety of its products are held by dedicated qualified person responsible for pharmacovigilance (QPPV) team engage in safety management.

The Applicant/Marketing authorization Holder is responsible for establishing the Pharmacovigilance System Master File and for registering the master file location with the competent authorities in the marketing authorization application.

Literature Search & Review

Literature Search & Reviewer

One benefit of contracting NUCLEON THERAPEUTICS, to carry out your Literature Screening for you is that we have been offering it as part of our range of drug safety services. Our staff have extensive experience in this area and can comprehensively manage your literature screening requirements in a cost-effective manner. Involving medical review of cases rather than adopting a mechanistic approach can also help to identify important signals in the literature.

A dynamic literature search is valuable source of information regarding toxicology reports, medical devices, medicinal products, adverse events execute in turn around time by an unfold team of post graduate pharmacist on multiple journal Conduct of searches via validated database eg-PubMed, NCBI, and Embase – Screening of Abstracts for identification of potential ICSRs. Screening of Abstracts for identification of potential new and significant safety findings for inclusion in PSURs. Understand and comply with the requirement to immediately notify regulators of new safety information from screening.

The qualified person responsible for Pharmacovigilance (QPPV) search the articles, abstracts and request for full article and translation. The medical team review of articles for inclusion in ICSRs, aggregate reports, signal detection and non-indexed journals. This workstation equipped with master database and DOS for fast and accurate features for eliminating redundant records and handling many thousands of citations. Multiple entry and re-verification of references are eliminated.