Cliantha works with the sponsors throughout their product development process.

• Well experienced team of Biostatisticians, SAS Programmers, PK Scientists and Statistical report writers
• Strong experience in understanding regulatory requirements
• Experience in handling different clinical studies like Crossover, Parallel, Partial replicate, Fully replicate, Steady state, Two-stage bioequivalence studies, SAD-MAD, Patient PK, Food effect, Dose proportionality, Drug-Drug interaction study, Sparse sampling PK study.
• Provides scientific inputs in study design, washout period and sampling timepoints
• Sample size estimation
• Randomization
• Protocol writing, SAP, TLF and CDISC datasets
• Impact assessment on protocol deviations by PK scientists
• PK/PD and statistical analysis using Phoenix® WinNonlin® and SAS® software
• Exploratory analysis, Interpretation for Bioequivalence results and way forward
• PK & Statistical analysis of Animal study as per CVM (Center for Veterinary Medicine) guidance.
• Regulatory query support

• All Statistical programmers are SAS certified (experience varies from 1 to 10 years)
• All Biostatistics are Master in Statistics (experience varies from 1 to 25 years)
• All PK Scientist are M. Pharm-Pharmacology (experience varies from 4 to 13 years)
• All Statistical report writers are Graduate/Postgraduate (experience varies from 2 to 15 years)

• Successfully completed 180+ studies for USFDA, EMA and ANVISA submission
• Strong study design and Statistical analysis experience of PK+ Adhesion + Irritation + Sensitization studies for different regulatory like USFDA, EMA and ANVISA
• Sample size estimation
• Randomization
• Protocol writing, SAP, TLF and CDISC datasets
• Impact assessment on protocol deviations by PK scientists
• Statistical analysis using SAS® software
• Exploratory analysis, Interpretation for Bioequivalence results and way forward
• Regulatory query support
• Our team has extensive experience with transdermal and topical drug delivery systems such as Lidocaine, Rivastigmine, Norelgestromin/Ethinyl Estradiol, Scopolamine, Clonidine, Buprenorphine, Rotigotine and related drugs

Human Repeat Insult Patch Testing (HRIPT) studies for safety assessment.

• Study design and protocol development for HRIPT studies
• Sample size calculations for sensitization studies
• Randomization schedules for patch testing
• Statistical analysis of irritation and sensitization data
• TLF generation for regulatory submissions
• Experience with cosmetics and topical product testing

Expertise

• Dedicated & experienced team of statistical programmers to provide CDISC submission package. Technical review team ensures accurate interpretation of SDTM / SEND and ADaM is applied in the package
• On-time: Whether it is a First-to-File, First-to-Market or a standard study, we commit to the timeline & meet it
• Delivers high quality & compliant services, cost-effectively
• Expertise across all Phases from Early Phase CDISC standards to post marketing Safety updates
• Regulatory experience in CDISC compliance submissions for FDA, PMDA, EMA etc

Services

• Strategic Consulting
• CDISC Standards Implementation
• Standardizing legacy data models and Data conversion
• Training of CDISC standards and Governance
• SEND Dataset Programming for Non-Clinical Data

CDISC Deliverables

• SDTM: Domain XPTs, Clinical Study Data Reviewer's Guide (cSDRG), Annotated CRF, Define.xml, Define.pdf, SDTM compliance validation performed using Pinnacle 21
• ADaM: Input from biostatistician, Domain XPTs, Analysis Data Reviewer's Guide (ADRG), Define.xml, Define.pdf, ADaM compliance validation performed using Pinnacle 21
• SEND : dataset creation and validation, Legacy data conversion to SEND, FDA compliance checking, Integrated toxicology and pharmacology data, Nonclinical Study Data Reviewer's Guide (nSDRG), Define.xml, Define.pdf, SEND compliance validation performed using Pinnacle 21.

• IVPT and IVRT studies
• Rheological statistical analysis
• Statistical calculation for CaCo2 studies
• Population bioequivalence analyses
• Equilibrium and kinetic binding analysis
• GI and NG Tube analysis
• Cut point analysis
• Dissolution comparisons using BCA or MSD

From design through analysis, Cliantha provides the service for demonstrating bioequivalence of topical corticosteroids.

• Successfully completed 55+ DRC-VASO studies for US and EMA submission.
• Study design including dosing timepoints of DRC VASO studies (ED50 and Emax)
• Dose response modeling and interpretation
• Exploratory analysis, Interpretation for Bioequivalence evaluations for the results and way forward.
• Regulatory query support
• Rich experience of DRC-VASO for different dosage forms (i.e Cream/Ointment/Lotion) for Desonide, Betamethasone, Halobetasol, Clobetasol, Fluocinonide, Mometasone, Hydrocortisone, Methylprednisolon and related drugs.

Statistical analysis of different types of Consumer Research studies as mentioned below.

• Development of protocols, CRFs, and Statistical Analysis Plans (SAPs)
• Sample size calculations
• Randomization schedules (parallel, crossover, factorial designs)
• TLFs (Tables, Listings, Figures) generation and review
• Delivering comprehensive statistical reports aligned with regulatory standards
• Translated statistical outcomes into actionable business insights

Execution of statistical strategy for consumer testing studies for above stated products

• Phoenix WinNonlin 8.7
• SAS 9.4 and SAS Viya 4.0
• PASS 25
• R software