- + 34 914 320 709
- hello@acrconsulting.eu
- Calle Fernando el Santo 27, Madrid, Spain
Precision and compliance are the cornerstones of effective medical writing. Our suite of Medical Writing services ensures your clinical documentation is scientifically accurate, regulatory-compliant, and delivered with unparalleled clarity. From Clinical Evaluation Reports to full Clinical Study Reports, our experts provide meticulous attention to detail to support your MedTech advancements from conception to conclusion.
Navigate the complexities of Clinical Evaluation Reports (CERs) with our expert medical writing team. We specialize in synthesizing clinical data and existing literature into comprehensive reports that support your medical device’s safety and performance throughout its lifecycle.
Lay the groundwork for successful clinical investigations with our meticulously crafted investigation plans. Our team ensures each plan is robust, compliant, and tailored to facilitate your study’s objectives, delivering actionable insights for your medical device’s journey to market.
Concluding your clinical trials with clarity and precision, our Clinical Study Reports articulate your findings in the context of regulatory standards. Our detailed analysis and clear summarization support your submissions and publications, ensuring your research resonates with regulatory authorities and the broader scientific community.
Crafting Clinical Evaluation Reports demands expertise and precision. Our services include:
Collating and summarizing clinical data pertinent to your device.
Ensuring reports are compliant with MEDDEV 2.7/1 rev 4 and MDR requirements.
Systematic search and appraisal of existing literature to support your CER.
Designing robust study protocols to meet international standards.
Preparing and submitting necessary documentation for regulatory approval.
Creating detailed plans for the statistical analysis of your study data.
Accurate Clinical Study Reports are the capstones of clinical research. We provide:
Expert analysis and interpretation of clinical study results.
Ensuring reports meet all regulatory and industry standards.
Concise documentation of study findings for submission to regulatory bodies.
