We provide end-to-end Clinical Data Management (CDM) solutions designed to support efficient, high-quality clinical trials. Our services include rapid clinical database development, integration of all clinical data sources, expert medical coding, streamlined query management, external vendor data oversight, database lock, and delivery of clean, audit-ready data.
At Cliantha, we offer comprehensive Clinical Data Management solutions tailored for pharmaceutical and biotech companies. From study design and EDC setup to discrepancy management, data review, study close-out, and regulatory compliance—we ensure accuracy, transparency, and speed. We prioritize precision in data collection, management processes, and clinical data strategy. Our dedicated focus ensures exceptional data quality, operational consistency, and long-term client partnerships Using advanced CDM platforms such as OneClinical, Inform, Rave, Medrio, and OCRDC, we deliver scalable, technology-enabled solutions that enhance data integrity, improve trial efficiency, and accelerate decision-making. As one of the leading clinical data management companies, we help sponsors advance their drug development programs with reliable, high-quality, and compliant clinical data.
Comprehensive Services. Consistent Data Excellence.
Protocol Review & Study Design Support
Expert input to ensure clarity, feasibility, and alignment between protocol requirements and database design.
EDC Design & Database Build
Robust, standards‑aligned database structures developed with speed and precision to support rapid study start‑up.
Data Validation Plan Development
Comprehensive edit checks and validation rules designed to enhance data accuracy and reduce downstream discrepancies.
Centralized Data Review & Reconciliation
Continuous oversight of clinical, safety, lab, and third‑party data to maintain consistency across sources.
Medical Coding
Accurate and compliant coding using global standards (MedDRA, WHODrug) to support reliable safety and efficacy analysis.
Query Management & Discrepancy Resolution
Streamlined communication and efficient issue resolution to keep data clean and timelines on track.
Third‑Party Data Integration & Vendor Management
Oversight of labs, imaging, ePRO, and other vendors, ensuring quality and adherence to SLAs.
Regulatory Compliance & Audit Readiness
Meticulous documentation and adherence to ICH‑GCP, CDISC, FDA, EMA, and other global requirements.
Database Lock & Study Close‑Out
Smooth and efficient project closure with complete, validated datasets ready for statistical analysis and submission.
Accuracy Powered by Expertise
Processes and Offerings
- Seamless Data management of Phase I-IV studies
- e-Pro and Diaries integration
- 18 Global SOPs
- Work instructions and training manuals
- All major therapeutic areas experience
- Global team
Multi-platform experience
- Medrio, Inform, Acceliant, Oracle Clinical (OC-RDC), Medidata Rave, Amedon
- Our team is flexible and adaptable, with the capability to accommodate sponsor-specific platforms and tools
Code Angelo
- Proprietary EDC tool
- 21 CFR part 11 compliant
- Web based
- Easy integration with other tools
- Faster database design
- Ad hoc reporting
- Used as EDC for 180+ studies
Early Phase (PK-BA/BE studies)
At Cliantha, we deliver robust clinical biostatistics and statistical programming solutions that drive confident decision-making across all phases of clinical research. Our experienced biostatistics team applies advanced statistical methodologies to ensure accurate data analysis, regulatory compliance, and high-quality clinical trial outcomes.
With expertise in SAS programming, CDISC standards (SDTM/ADaM), and statistical analysis plans (SAPs), Cliantha supports end-to-end data strategy—from protocol design and sample size calculation to final study reports and regulatory submissions. Our solutions are aligned with global regulatory expectations including ICH-GCP, FDA, and EMA guidelines.
Partner with Cliantha for data-driven insights, timely deliverables, and exceptional quality in every statistical output. Discover how our clinical biostatistics and programming expertise can streamline your next study.
Leverage 21 years of experience and cutting-edge technology to elevate your clinical trial success
- Healthy and Patient PK/PD , 2/3/4 Way Cross Over, Parallel, Multiple dose, SAD-MAD, Two-stage adaptive design, DRC-Vasoconstriction studies, Adhesion, Irritation and Sensitization (HRIPT) analysis
- SAS, R, WinNonlin, PASS
Type of studies
Software tools
Services
- Feasibility for study design, sampling time points, washout period
- Sample size
- Protocol inputs
- SAP & TLF Mock Shells
- PK & Statistical analysis
- CDISC (SDTM, ADaM and Documentation)
- TFL programming and validation
- Statistical report writing
- eCTD compilation
- Regulatory query support
Late Phase (Clinical end point studies)
- Non-inferiority, Superiority, Equivalence, Post Mkg S, exploratory studies
- SAS, R, PASS
Type of studies
Software tools
Services
- Feasibility for study design (NI, Superiority, Equivalence)
- Sample size
- Protocol inputs
- SAP & TLF efficacy & safety mock shells
- CDISC (SDTM, ADaM and Documentation)
- TFL programming and validation
- Statistical report writing
- eCTD compilation
- Regulatory query support
Type of studies
- Kinetic Binding, Population BioEquivalence, IVRT, IVPT, NasoGastric tube…
Services
- Protocol inputs
- Statistical analysis
- Statistical report
- eCTD compilation
Consumer Research Studies
- Claim Substantiation studies, Efficacy studies, Safety studies
Type of studies
- Feasibility for study design (NI, Superiority, Equivalence)
- Sample size
- Protocol inputs
- Statistical analysis
- Statistical report
Services
eCTD compilation
Specialized expertise across therapeutic areas and development phases
- USFDA, EU, Canada, ANVISA, and other global regulatory authorities
- Acrobat PDF writer and PlugIn
Global Submissions
Tools
Ectd Expertise (for all the Ectd COMPILATIONS )
- Bookmark
- Internal and external Hyperlink
- TOC (Table of contents)
- Embedded fonts
- Inherit Zoom (bookmark & link)
- Page rotation and pagination
- OCR
