(EU) No. 536/2014: the impact of the new clinical trials regulation
Are you prepared to navigate the evolving regulatory requirements of the Clinical Trials Regulation (EU) No 536/2014? Have you aligned your human capital, technologies, and processes to ensure overall compliance? While this harmonized regulation will help gain efficiencies, it will also require significant changes to how and when you prepare, submit, and report your applications during this phased implementation period.
How CQ fluency is prepared to partner with you:
we build workflows that support stricter deadlines
• We centralize, securely and efficiently submit your multi-language translation requests through one customizable portal and adapt as necessary as your needs grow or change.
• We provide more than one layer of trial IDs to track and report while adhering to your compliance requirements.
• We build dashboards to run reports based on several datapoints to gain visibility into project/trial status.
• We customize your clinical translation process with our ISO 9001 and ISO 17100 certified workflow procedures. Our processes are in full compliance with the ISPOR Principles of Good Practice for Translation and Cultural Adaptation of PROs and ISOQOL guidelines.
we partner with you during the initial assessment phase
• We help connect the dots when submitting documents for the application dossier.
• We know it’s important to start the localization/translation discussion upstream when the source language master documents are being developed because new regulations often provide less flexibility submitting substantial modifications.
we optimize translation efficiency to ensure accuracy and a quick turnaround
• We help connect the dots when submitting documents for the application dossier.
• We know it’s important to start the localization/translation discussion upstream when the source language master documents are being developed because new regulations often provide less flexibility submitting substantial modifications.
we automate and optimize the process to your benefit
• We map out the steps to safely implement automation at the appropriate times and we advise of the potential benefits and risks.
• We optimize human touch points so your team spends less time moving files around and spends more time making key decisions on project success in terms of quality, timeliness, and budget.
• We integrate your existing platforms with our customized CQportal to simplify production, increase transparency, and improve security, while ensuring there is a consistent information flow of data into a centralized Translation Memory System.
we help prepare plain-language summaries (PLSs)
• We understand that simplifying copy cannot be misleading.
• We operate with standard operating procedures (SOPs) for handling and processing the PLSs based on your requirements.
• We ensure dialects and cultural cues are considered, provide back-translations and in-country reviews.
• We also leverage tools to evaluate reading level such as multi-lingual glossaries of critical words to flag.
we offer consulting services on multi-lingual clinical labeling
• We offer regulatory consulting services to advise you on how to condense copy by abbreviating, rephrasing and/or using acronyms.
we set up translation workflows to meet urgent reporting timelines for SAEs/SUSARs/CIOMS/ within 24–72 hours
• For a leading pharmaceutical client, we developed an automated process to rapidly translate flagged articles from global medical journals. Our automation solution sifted through extensive amounts of multilingual data to identify any potential adverse events. Once flagged, these articles were expedited to SME linguists for translation. For life-threatening/critical content, we translated within two business days or four calendar days (whichever was shorter), and all other articles were translated within three business days or five calendar days (whichever was shorter).
• We can develop custom glossaries of key words across multiple languages and build automated workflows to rapidly identify and flag key words.
we are structured to support urgent requests
• We have off-hour and weekend personnel.
• Our efficient tech-enabled translation processes ensure accuracy, quality and timely delivery.
• We collaborate with you to continually evolve processes to increase efficiencies.
• Our 1500+ expert linguists worldwide along with our committed project managers adhere to your KPIs on quality, cost, responsiveness, and turnaround times.
WHY CQ fluency
- We have a deep understanding of the life sciences industry that allows us to truly help our global pharmaceutical clients navigate evolving regulatory requirements.
- We take the time to understand your specific challenges.
- Our nimble, collaborative culture which allows us to apply experiences from across our customers (world’s largest pharmaceutical companies) to ensure we properly address your needs.
- We are prepared to implement customized workflows so that submission accuracy and deadlines are always met.
…more reasons WHY
- We have built a powerful reputation in the scientific community through our connections with well-respected clinicians worldwide.
- We have become the trusted regulatory advisor for many of our pharmaceutical clients with our network of in-country experts.
- We and our partners have worked on over 50 complete studies. On average, each study covers 15 languages/countries.
- We have participated in multiple studies pertaining to various therapeutic areas which enables us to continuously build on our expertise with every project we take on for our valued clients
We are prepared to partner with you to help navigate current and new regulatory changes and the impact they may or may not have on your translation strategies. Contact us today to request a copy of our Readiness for EU Clinical Trials Regulation Overview.