Our Services
- Abstract (ABST)
- Ad-hoc Analyses
- Biometrics
- Briefing Document (BRD) / Briefing Book
- Briefing Package Review
- Case Report
- Case Report Form (CRF)
- Clinical Development Plan
- Clinical Evaluation Plan (CEP)
- Clinical Evaluation Report (CER)
- Clinical Investigation Plan (CIP)
- Clinical Investigation Report (CIR)
- Clinical Overview (CLO)
- Clinical Study Report (including narratives) (CSR)
- Clinical Summary
- Clinical Trial Protocol (CTP)
- Common Technical Document (CTD)
- CSR statistical Authorship
- Development Safety Update Report (DSUR)
- Digital content and visualization
- Editorial
- Educational or Promotional Materials
- Electronic Informed Consent Form (eICF)
- General Investigational Plan (GIP)
- Informed Consent Form (ICF)
- Investigator’s Brochure (IB)
- Layperson Summary/Plain Language Summary (PLS)
- Life Focus Groups
- Literature Review
- Manuscript (MSCT)
- Medical Translations
- Meeting & Conference Report (MCR)
- Narrative (NARR)
- Online Panel Survey
- Pediatric Investigation/Study Plan (PIP/PSP)
- Periodic Benefit-risk Evaluation Report (PBRER)
- Pharmacovigilance Plan (PV Plan)
- Previous Human Experience (PHE)
- Protocol Review
- Quality Control Services (QC)
- Randomization
- Response Documents/Response to Questions (RtQ)
- Review CRF – Case Report Form
- Risk Evaluation and Mitigation Strategies (REMS)
- Risk Management Plan (RMP)
- Sample Size
- Scientific Poster (PSTR)
- Statistical Analysis Plan – Writing & Review
- Statistical Consultancy
- Statistical Expertise and Support
- Study Design
- Study objectives & Endpoints
- Summary of Clinical Efficacy (SCE)
- Summary of Clinical Safety (SCS)
- Summary of Results
- Support DSMB, Interim and DMC meetings (Charter, member, data presentation, meeting report)
- Support publications (Abstracts, Posters)
- Tailored Courses
- Training Good Reviewing Practices
- Training Inclusive Writing
- Training Key Documents in Drug Life Cycle
- Training Lean Writing
- Training Overview of Study Types and Designs
- Training Scientific Article Writing
- Training Sessions
- Transform Data into Graphics and Dashboards
Emtex at a glance
Some key facts about Emtex.
21
Years
of experience
1307
Projects
completed
21
Team
members
48
Customers
worldwide
Value for you
- Emtex delivers high quality
- Emtex helps freeing your time & resources
- Emtex gives cost-effective solutions
- Emtex ensures continuity and long-term relationships