At EDETEK, we understand that the success of any trial is measured by data quality. Our biostatistics and data management professionals focus on this, incorporating efficiencies throughout the lifecycle of a project and tailoring our clients’ needs to meet all desired outcomes. Our comprehensive services assure optimized trial design, regulatory compliance, and data integrity. EDETEK’s services include clinical data management, biostatistics, programming, data standardization, enterprise standard development, clinical informatics, and computational environment hosting. We participated in more than fifteen submissions to regulatory agencies (e.g., FDA, PMDA, EMA, Health Canada) in the last two years across various therapeutic areas including Oncology, CNS, Cardiovascular, Vaccine, Infectious Disease, Immunology, Dermatology, Ophthalmology, Pain, Rare Disease, and Gene Therapy, to name a few.
EDETEK Biostatistics & Clinical Programming services deliver high-quality statistical analysis and data programming solutions to support clinical trials from design to submission. Our services include SDTM, ADaM, TLF, IB/DSUR/DMC, FDA Briefing Book, Publication Support, BIMO, Patient Profile, Patient Narratives, Data Review List, PDF Listing and Smart Listing. In addition, we perform data masking, data scrambling for blinded studies, as well as de-identification/anonymization based on special regulatory requirements.
Study Design & Statistical Consulting – Expert guidance on trial design, sample size calculation, and statistical methodologies.
Statistical Analysis Plan (SAP) Development – Comprehensive SAP creation to ensure robust and regulatory-compliant analysis.
Clinical Programming (CDISC, SDTM, ADaM) – Efficient data structuring and transformation following CDISC standards.
Statistical Analysis & Reporting – Generation of tables, listings, and figures (TLFs), Patient Profiles and Study Profiles for clinical trial results.
Regulatory Submission Support – Preparation of datasets and statistical documentation for FDA, EMA, and other agencies.
Company Data Standard Development – Creation of Data Collection, Review, Analysis and Submission standards of normalized programming and reporting
ISS/ISE, Interim Analysis, Submission – Generation of Integrated Summary of Safety (ISS) & Integrated Summary of Efficacy (ISE) reports to support study data analysis and regulatory submissions
With a focus on precision, compliance, and efficiency, our biostatistics and clinical programming experts help transform complex data into actionable insights for regulatory success.
Our Clinical Data Management (CDM) services ensure the integrity, accuracy, and compliance of clinical trial data from start to finish. We provide end-to-end solutions tailored to pharmaceutical, biotech, and medical device companies, optimizing efficiency while meeting regulatory standards.
With a commitment to accuracy, compliance, and efficiency, our expert CDM team helps you transform raw clinical data into reliable insights for informed decision-making.
Our Clinical Study Development services provide end-to-end support for the planning, design, and execution of clinical trials. We help pharmaceutical, biotech, and medical device companies develop scientifically sound and regulatory-compliant study protocols to accelerate drug development.
Clinical Development Plan (CDP) – Strategic roadmap outlining the clinical trial phases, objectives, and regulatory pathways.
Protocol Development – Expertly designed study protocols defining trial methodology, endpoints, and inclusion/exclusion criteria.
Site Documentation – Preparation of essential regulatory documents, including Investigator Brochures, Informed Consent Forms (ICF), and Site Initiation Materials.
Statistical Analysis Plan (SAP) – Detailed framework for statistical methodologies, endpoints, and data analysis strategies.
Data Management Plan (DMP) – A structured approach to data collection, validation, and compliance with regulatory standards.
Randomization Schedule – Design and implementation of randomization methodologies to maintain trial integrity and minimize bias.
With a focus on compliance, efficiency, and scientific rigor, our clinical study development experts help bring your trial from concept to execution.
Our eClinical Operations services provide seamless execution and management of clinical trials, ensuring efficiency, compliance, and data integrity. We support pharmaceutical, biotech, and medical device companies with end-to-end operational solutions for smooth study conduct.
EDC Start-Up & Conduct Support – Efficient setup and management of Electronic Data Capture (EDC) systems for streamlined data collection.
Fast Protocol Amendment Support – Rapid implementation of protocol changes to maintain study timelines and compliance.
CRF Design & Database Setup – Custom Case Report Form (CRF) design and database configuration for accurate data capture.
eTMF Configuration & Support – Electronic Trial Master File (eTMF) setup and management for real-time document tracking and regulatory compliance.
IWRS & CTMS Setup – Interactive Web Response System (IWRS) and Clinical Trial Management System (CTMS) implementation for optimized trial operations.
Randomization & Trial Supply Management – Robust randomization strategies and supply chain solutions to ensure uninterrupted study conduct.
AE/SAE Recording & Reporting – Comprehensive adverse event (AE) and serious adverse event (SAE) tracking, reporting, and regulatory submissions.
With a focus on quality, compliance, and operational efficiency, our clinical operations team ensures your trial runs smoothly from start to finish.
Let’s work together to streamline your clinical study operations!
Our Medical Writing services provide clear, accurate, and regulatory-compliant documentation to support clinical development and regulatory submissions. We help pharmaceutical, biotech, and medical device companies effectively communicate study results with precision and compliance.
ICH-Compliant & Abbreviated Clinical Study Reports (CSR) – Comprehensive and summary reports aligned with ICH guidelines for regulatory submissions.
Statistical Summaries – Clear, data-driven reports summarizing key statistical findings from clinical trials.
SAE Narratives – Detailed, concise documentation of serious adverse events (SAEs) for regulatory reporting.
ISS/ISE Data Packages – Integrated Summaries of Safety (ISS) and Efficacy (ISE) to support new drug applications (NDAs) and regulatory filings.
Electronic Common Technical Document (eCTD) Preparation – Well-structured, submission-ready modules formatted for electronic regulatory submissions.
With a commitment to clarity, compliance, and scientific accuracy, our expert medical writers ensure your documentation meets the highest regulatory standards.
Let’s collaborate to bring your clinical data to life with precise and impactful medical writing!
