Consulting/Outsource Services
Medical Writing Services
Scientific Communications
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.
Regulatory medical writing :
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).
Clinical Writing
In the dynamic landscape of drug development, our experts bring extensive experience to the table. From crafting Clinical Study Protocols, Informed Consent Documents, to develop most important Investigator Brochures, our team is well-versed in producing critical documents essential during various phases of drug development.
Our Clinical experts handle patient safety narratives with precision, reflecting our commitment to delivering the best results and so developing clinical study reports (CSRs) became our strength whether they are for highly specialised therapy areas or for medical devices .
Allow our experts to comprehend your unique requirements, ensuring that the deliverables not only meet but exceed your expectations. At Clini Resource, we prioritize excellence in medical writing to support your objectives effectively.
Medical Information and Clinical Trial Unblinding
CliniResource offers specialist services to cover your Medical Information need for post-approval products and emergency unblinding need for your ongoing clinical Trials. We’re available to cover your need 24 hours a day, seven days a week.
Medical Inquiries/Product Complaints:
At Clini Resource, we take pride in our comprehensive Medical Information Services, which include a dedicated response center equipped with cutting-edge technology, instruments, and a highly-trained team of healthcare professionals. Our focus is on efficiently receiving, triaging, and responding to medical inquiries, product quality concerns, and Adverse Drug Reaction (ADR) complaints related to medical products authorized for our clients in English-speaking countries.
Our Response Center operates with precision, ensuring that each inquiry and complaint is handled with the utmost care. We provide a dedicated line for receiving calls and facilitating follow-ups to address product complaints associated with ADRs. Our 24/7 physician team, specializing in the relevant therapeutic areas, stands ready to respond promptly and effectively.
Our physicians are not only well-versed in clinical matters but are also trained to deliver standardised responses. This includes providing Frequently Asked Questions (FAQs) and comprehensive answers concerning medical inquiries and product ADR complaints. Communication channels include email, fax, or even postal mail by courier, ensuring flexibility and convenience for our clients.
Emergency Unblinding during Ongoing Clinical Trails:
Our unparalleled clinical experience in providing 24/7 emergency response services allows us to offer strategic solutions to small, medium and global pharma companies. We offer an immediate, ever-present point of contact regarding any help or information that is required during Clinical Trials. Our 24/7 standby clinical experts minimise the response timeline to 30 minutes for each unblinding request from the trial site. They also ensure the trail unblinding when it is deemed necessary. Medical Information team further ensures SAEs reporting to the Sponsor Pharmacovigilance within 24 hours.Clini Resource’s 24/7 global medical response service ensured the client’s commitment to patient safety and compliance with ICH -GCP regulations.
Regulatory Affairs Services
CliniResource offers expert guidance and regulatory submission support throughout the entire development and launch processes within EU, US and Asia-Pacific. Our experts plan and coordinate every detail of a clear and complete US/European submissions.
We provide consulting services for (key submissions)-
-
Pre-Approvals- examples-
-
Filling of Investigational New Drug (IND),
-
Orphan Drug Designation (ODD),
-
Biologics License Applications (BLA),
-
Investigational Device Exemptions (IDE),
-
CE filings and Pre-Market Approval (PMA)
MAA/NDA- examples-
-
New Drug Application (NDA)
-
Abbreviated New Drug Application (ANDA)
-
Marketing Authorization Applications (MAA) within EU
-
ATC code applications
Post-Approvals- example-
-
Variations/Renewals
-
MA transfers
-
Reclassifications
Regulatory Intelligence
Our dedicated team meticulously monitors global regulatory landscapes, ensuring that our clients stay abreast of any changes. We provide timely updates on regulatory discussions, decisions, and safety-related recommendations for products/molecules authorized on behalf of our clients. Through detailed meeting minutes, we keep our clients and their teams well-informed.
Regulatory communications
Our highly skilled team, well-versed in all aspects of regulatory communication, supports clients in crafting and managing comprehensive responses to inquiries from Health Authorities. These responses may pertain to product safety issues arising from PSURs, RMPs, and other reports. Additionally, we assist in preparing letters in response to recent regulatory inspections or commitments made during prior regulatory inspections.