Global and Local Literature Search Screening

Screening published medical and scientific literature regarding medical devices, and medicinal products is a mandatory requirement for marketing authorization holder (MAH) or License holders. MAHs need to regularly monitor the literature for suspected Adverse Drug Reactions (ADRs) and other information, including potential drug interaction, misuse, off-label use, and class effects.

Pepgra offers pharmacovigilance Literature review search services as part of the drug safety and efficacy services. Our medical regulatory staff have extensive experience in searching for articles from multiple databases published and can comprehensively manage your literature screening requirement in a cost-effective manner in conjunction with writing periodic safety reports. Our literature specialist team of Pepgra has 15+ years of experience in global pharma, with a focus on literature. We work closely with customers on one-on-engagement model and develop the search strategy methodology to ensure that criteria are robust and an unbiased approach. We perform the literature search be for aggregate reports, or benefit-risk analyses or for signal evaluation or ongoing screening as required by local and regional requirement. Our weekly search is not only limited to the identification of individual case safety reports but also detection of safety issues. We can conduct literature screening as per your requirement in local territories.

Our pharmacovigilance researchers are aware of the standard pharmacovigilance guidelines and regulations, including 21 CFR part 314.80 and 600.80 and basics of clinical development of a drug. In addition, our reports will be prepared based on ICH E2C (R2) PBRER and other reports (PFSB/SD 0917/2; PFSB/SD 0216/2; PFSB/SD 033 /9). Our writers also aware of data protection /privacy regulations, and work under stringent timelines in tandem with multiple stakeholders who might have different opinions, to arrive at a suitable consensus in a timely manner.

Our local representatives perform the review of specific local-non-indexed scientific and medical journals for the identification and processing of ICSRs.

Our Comprehensive Literature Review Screening Solutions

• Identification of Studies: Our experts conduct searches through validated databases including Embase, Medline or other local country-specific publications (e.g. JDream Databases for Japan) and screen abstracts for identification of potential ICSRs. We notify immediately of new safety information from screening.
• Regular Reviewing of local (non-indexed) Journals and documentation of all serious, unexpected adverse reactions (AR) and non-serious adverse reactions reported in the scientific literature. Even if there are no ARs, an ASR will be prepared and shared. In case reports present evidence of any serious, suspected adverse reactions, it would be forwarded receipt immediately.
• Literature Review Protocol identifying the elements, including the background, objectives, and methods for identification, selection and collection of the relevant publication to address literature review questions. Full published articles will be shared as per the order in which they have been used. Full quality checked report.
• Abstracts screening for identification of potential new and significant safety findings for inclusion in PSURs. The following information will be collected, as appropriate.
• Pregnancy outcome with no adverse events.
• Compassionate supply named patient use
• Asymptomatic overdose, abuse or misuse
• Off-label use, class effects
• Drug/food interaction, the suspected transmission of an infection’s agent
• Use in pediatric, elderly or organ impaired population
• Any other important non-clinical safety results. Ordering selected full publications for evaluation of ICSRs or safety issues