Navigating the EU Clinical Trials Regulation:
Understand, Adapt, & Succeed with MMS Holdings
Introduction to the EU Clinical Trials Regulation
The EU Clinical Trials Regulation was introduced to transform the clinical trial landscape by:
- Streamlining the clinical trial application process with National Competent Authorities and Ethics Committees.
- Boosting transparency and data accessibility in clinical trials.
Why Pharma Companies Should Be Proactive
If you’re a pharmaceutical company, consider the following:
- Regulatory Compliance: Complying with the new regulation isn’t merely a legal necessity; it’s a proactive step toward streamlining processes and enhancing patient safety.
- Transparency as a Trust Builder: A commitment to transparency means your stakeholders, patients, and partners can trust your trials more.
- Operational Excellence: A unified application process cuts down on administrative challenges, making trial approvals smoother and quicker.
How MMS Assists You in Navigating the EU Clinical Trials Regulation
Why Choose MMS?
- Established Expertise: As a data-focused CRO, MMS leads the way in regulatory submissions, with an impressive 97% customer satisfaction rate.
- Holistic Approach: Our team, made up of SMEs from Regulatory Strategy to Transparency, ensures you receive a comprehensive suite of services.
Dive Into Our Core Services:
MMS Regulatory Affairs
- Strategic Consulting and Direct Regulatory Communication
- Coordinating submissions in tandem with your clinical or regulatory groups
- Consolidating data entry and uploads to CTIS, leveraging our CTIS tracker as a reliable reference for all updates
- Efficient portal monitoring and document management
MMS Clinical Trial Transparency
- A seasoned team adept at PPD and CCI redactions
- Orchestrating reviews with your clinical, regulatory, and legal entities
- PoCs skilled at guiding, facilitating, and pinpointing reasons for CCI
- Crafting consistent dossiers reusable for other disclosure needs like CT.gov, HC-PRCI, and EMA Policy 0070 submissions
- Comprehensive Dossier Disclosure Support
MMS Regulatory and Medical Writing
- Skilled writers utilize lean authoring techniques and practices in line with CTR
- GAP analysis and refining your templates for portal compatibility
- Precision authoring to limit the reliance on PPD and CCI
Seek Expert Advice on Any Topic!
BlogCTIS Updates: Cross-Functional Teams are Needed for Success
The CTIS is a single portal for European Union (EU) competent authority and ethics submissions for clinical trial applications (CTAs) across EU member states.
BlogHow does the EU-CTIS Affect Clinical Trial Transparency?
On 31 January 2022, the EU-CTR 536/2014 replaced the long-standing directive, the European Union (EU) Clinical Trial Directive 2001/20/EC (commonly known as EU‑CTD).
BlogHow to Train Users on the CTIS Ahead of New Regulations
On 31 July 2021, the European Commission published a notice in the Official Journal of the EU announcing that the EU Portal and Database, a key component of the CTIS, is fully functional.
BlogEMA Policy 0070: Much Awaited Revamp for Clinical Trial Transparency
On May 16th, 2023, EMA conducted a much-awaited webinar to address the phased restart of EMA Policy 0070 after almost five years of suspension. The restart will come into effect in September 2023.
BlogConducting Quantitative Risk Assessments for Anonymized Datasets and Documents
Data anonymization and document anonymization in clinical trial data is now more important than ever.
WebinarEU Clinical Trials Regulation: The Clinical Trial Transparency Revolution
The EU CTR (Regulation No 536/2014) will enter in force in January 2022, changing clinical trial processes in Europe and impacting clinical trial activities worldwide.
About MMS Holdings
Established by Dr. Uma Sharma in 2006, MMS Holdings (MMS) has evolved from a solo consultancy into an international CRO powerhouse, boasting a team of over 800 professionals globally. At MMS, our mission is anchored in delivering top-tier services and technological solutions grounded in deep scientific knowledge and extensive regulatory expertise.
MMS stands as a forward-thinking, data-focused CRO that champions the pharmaceutical and biotech sectors. Our robust blend of industry experience, cutting-edge service offerings, and a data-first approach to drug development cements our reputation as a prime CRO partner, consistently producing regulatory submissions that meet the strictest of standards. With an expansive presence spanning four continents, MMS upholds an enviable 97% customer satisfaction rate.
Let MMS Guide You Through the Complexities of the EU Clinical Trials Regulation.
Reach out to our Experts to discover how MMS can streamline your clinical trial submission and guarantee adherence to the latest EU Clinical Trials Regulation. We’re eager to collaborate and support your quest for triumphant clinical trials.
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