eCTD Services:
Submissions
Our Biostatistics and Medical Writing teams work closely together to deliver services that cover all aspects of the regulatory submission process. From CDISC conversion to integration, writing, and submission validation, our experienced team knows how to assemble a successful electronic data package.
eCTD services delivered with Precision
Let our efficient, process-driven excellence manage your submission needs
Handling all aspects of the eCTD process
- CDISC programming and conversion
- SAPs for safety and efficacy integration
- Programming integrated datasets in CDISC-compliant format
- Assembly of tables, figures, and listings (TFLs)
- Preparation of overviews and summaries
- Assembly of quality data
- Submission and validation
Experienced in meeting global eCTD services needs
- Global regulatory expertise
- Global eCTD submission experience
- 100% submissions accepted
“We know how important it is to get your submission right the first time, and how critical it is to respond quickly and accurately to questions from the regulatory agencies.”
Elizabeth Ludington
Senior Vice President, Biometrics
“We know how important it is to get your submission right the first time, and how critical it is to respond quickly and accurately to questions from the regulatory agencies.”
Elizabeth Ludington
Senior Vice President, Biometrics
Tell us about your project requirements
The deep experience and successful track record of our biostatistics team are just two of the many reasons to choose Precision for Medicine. Contact us to learn more.
Tell us about your project requirements
The deep experience and successful track record of our biostatistics team are just two of the many reasons to choose Precision for Medicine. Contact us to learn more.
Clinical trial services
Global Clinical Trial Footprint
Sample processing labs, clinical trial sites and offices in five continents provide the clinical reach and scale to manage complex global programs.
Clinical Development Strategy
Tailored strategies consider the scientific, regulatory, and commercial factors that shape each trial, mitigating risk and advancing the development pathway.
Clinical Trial Design
Advanced trial-design approaches—including basket, umbrella, and adaptive trials—deliver biomarker driven clinical research. Deep experience in these highly complex trial designs maximizes both insights and efficiency.
Biostatistics
Seasoned biostatisticians and statistical programmers deliver insight into every trial phase, from study design to regulatory submissions, all backed by meticulous documentation and data monitoring.
Clinical Sample Management
Sample inventories from a global network of labs supply real-time processing in 55 countries; consolidated data from central labs, screening labs, and specialty labs with clinical data create actionable reports.
