Medical Writing
"Transforming complex medical concepts into clear, accurate, and impactful content that drives innovation, understanding, and patient care"
Benefit/Risk Reports
“Evaluating Safety and Efficacy for Informed Decision-Making.”
In pharmacovigilance, Benefit/Risk (B/R) assessments are essential for evaluating the overall safety and efficacy of a medication. These reports provide an in-depth analysis of the positive effects versus potential risks, enabling stakeholders to make informed decisions about the continued use of a drug.
At CliniResource, we take a data-driven, scientifically rigorous approach to Benefit/Risk report writing, ensuring that the evaluation reflects a clear understanding of the therapeutic benefits and associated risks of a medicinal product.
Aggregate reports- PSURs, PBRERs, DSURs, ACOs & PADERs
“Comprehensive Safety and Efficacy Analysis for Regulatory Compliance.”
Our expert writing services of clinical aggregate reports included but not limited to Periodic benefit-risk evaluation reports (PBRERs), Periodic safety update reports (PSURs), Periodic adverse drug experience reports (PADERs), Addendum to clinical overview (ACOs) Development safety update reports (DSURs), Annual safety report s(ASRs) and Clinical expert statements (CESs).
Our services include their preparation to publishing of reports and submission in electronic common technical document (eCTD) format through submission portals of various regulators.
The Aggregate Safety Report in pharmacovigilance serves as a comprehensive summary of safety information related to a medicinal product, consolidating data from various sources, including clinical trials, spontaneous reports, literature, and other relevant sources. This crucial document provides a holistic perspective on the product's safety profile by analyzing adverse events, risk-benefit assessments, and trends over time. The compilation of aggregate safety data enables regulatory authorities, healthcare professionals, and MAHs to make informed decisions about the continued use of the drug, ensuring patient safety and the ongoing monitoring of potential risks associated with the medication.
This proactive approach to pharmacovigilance plays a pivotal role in maintaining and enhancing the overall safety of medicinal products throughout their lifecycle. CliniResource’s strength lies in the in-depth analysis of the benefit-risk ratio of medicinal products and medical devices.
Risk management plans (RMPs) and REMS
“Ensuring Safety and Regulatory
Compliance.”
These specialist documents are the one with most confusion and lack of clarity. Where REMS are moreover Med Guides and or Communication Plans, EU RMPs are more detailed and in some instances additional safety measures may be required in which case an additional Risk Minimization Measures (aRMM) are required. This may lead to large number of regulatory returns with many requests for update and expansion.
CliniResource excels in addressing the complexities of these documents, providing experienced therapeutic area experts to assist in planning and preparation of Additional Risk Minimization Measures (aRMM) such as drafting of educational materials; educating/training the HCPs and setting up of patient registries, tracking and effectiveness check for these aRMMs and if required preparing of additional PV activities such as targeted follow-up questionnaires and its periodic review. Thus we navigate challenging requests, ensuring maximum satisfaction with relevant Regulatory Authorities.
Writing SOPs and technical documents
“PV system setup.”
Our in-house quality management system makes sure that we are always on our toes when it comes to quality and compliance. Core pharmacovigilance professionals are involved to ensure the expectations. Regular internal audits ensure that our trainings, SOP reviews and document management are up-to-date so that we are always audit-ready for our clients and regulators.
Everyone who is inducted into the organization is thoroughly trained on our internal quality procedures to ensure complete client satisfaction and regulatory compliance.
As we at CliniResource understands that quality management system is a backbone for an organisation and is the most complex system which faces the most ignorance, we also offer customised quality management services to our clients by understanding their need. Risk management plans/REMS/ Safety update reports writing.
These specialist documents are the one with most confusion and lack of clarity. Where REMS are moreover Med Guides and or Communication Plans, EU RMPs are more detailed and in some instances additional safety measures may be required in which case a Risk Minimization Plan is required. This may lead to large number of regulatory returns with many requests for update and expansion.
We at CliniResource are well experienced, facing and responding such challenging requests. Out therapeutic area experts assist in preparation of these tricky documents, and help our client to reach at the maximum satisfaction of relevant Regulatory Authority.
Writing product information, PILs, SmPCs, CCD
“Clear, Compliant, and Patient-Centric
Communication.”
Navigating the intricacies of regulatory submissions demands precision and expertise. The Common Technical Document (CTD) is a globally accepted format for applications related to new drug registrations.
Our team at Clini Resource specialises in preparing dossiers for generic drug filings in key regions such as the EU, US, Canada, Gulf countries, CIS, and India. Proficient in handling both clinical and non-clinical aspects, we are adept at crafting documents for electronic submission (eCTD), including clinical and non-clinical overviews, as well as IND/NDAs, ensuring compliance and thoroughness. We are expert drafting Patient Information Leaflets (PIL) and Summary of Product Characteristics (SmPC) based on the local regulatory need.
Our clinical experts are efficient to conduct a comprehensive assessment of global product information to draft Company Core Data Sheet (CCDS) or Company Core Safety Information (CCSI).
Regulatory feedback
“Navigating the Path to Compliance and Market Approval.”
Our dedicated team of medical and scientific writers stands ready to deliver consistently high-quality scientific writing with proven benefits. Capable of crafting a variety of scientific communications crucial for the marketing of medicinal products, our experts excel in creating manuscripts, writing abstracts of scientific nature, posters, and designing monographs. Rely on our experienced professionals to enhance the scientific impact of your medical content.