Biometrics

Biometrics

Our PK and Biostatistics group is a solid performer for our Sponsors. They have worked on thousands of studies for most global markets. The team has the expertise, extensive knowledge and commitment to provide you with your submission ready report on time. Whether it is complex PK/ statistics or routine analysis, our team of scientists perform to exacting standards in compliance with ICH, FDA, EMA and other relevant regulatory standards.

The Pharmacokinetics & Biostatistics team at Cliantha Research supports the analysis of:

  • Study designs with primary and secondary end points
  • Sample size estimation
  • Randomization scheme
  • Statistical analysis plans

The Pharmacokinetics & Biostatistics team at Cliantha Research supports the analysis with:

  • Phoenix® WinNonlin®
  • SAS®
Pharmacokinetics & Biostatistics
  • Phase I and Phase II studies
  • Bioavailability & Bioequivalence studies (BA/BE in Healthy subjects and Patient)
  • Pre-Clinical / Toxicology studies
  • Study requiring Bootstrap analysis
  • Cut point & sensitivity for Immunogenicity data
  • Equilibrium & Kinetic Binding data
  • Topical and Transdermal patch (HRIPT, Adhesion, Irritation and Sensitization)

The team has a proud record of successfully completed regulatory audits without any observations including 483s

  • FDA
  • AGES
  • EMA
  • AEMPS
  • ANSM
  • MHRA
  • MCC
  • TURKEY MoH
  • WHO
  • THAILAND MoPH

Cliantha’s PK and Biostatistics team have completed more than 2200 studies with the following designs:

2-Way Crossover
3-way / 4-way reference replicate
Parallel
Urine analysis studies
Multiple dose / Steady State
Centralize Report Compilation (CRC)

Once Cliantha Research performs the Clinic, bioanalytical, PK and Biostatistics, the reports must be complied into a single submission ready document. Our group in the CRC compiles the clinical, analytical, PK and statistical reports as per eCTD format with Bookmarking, Hyperlink (Internal & External) and OCR.

Special knowledge and experience:
  • Team has rich experience of participation in pre-IND meeting with the FDA
  • Robust process, SOPs and compliance to all regulatory guidelines
  • Strong understanding of Statistical and Regulatory requirement
Clinical Trial Data Management Solutions
Clinical Data Management
  • Complete Clinical Data Management services from CRF Design , Deploying the database, Query generation to Database Lock (DBL) for both eCRF & Paper studies
  • Robust IT infrastructure ensures your data security, privacy & uninterrupted services
  • Rich experience of working with industry renowned CDM systems like Rave®, Inform®, Medrio®, kTrialsTM, Acceliant, Omnicomm, SAS PheedIT, ClinTrial , etc.
  • Efficient and tested processes with detailed documentation including SOPs, working procedures & study specific documents to comply with ICH standards, national regulations & guidelines
  • Highly skilled talent pool, who have worked on Phase I-IV trials for a variety of therapeutic areas including Biologics and Biosimilars
  • Stringent quality procedures including senior review (QC) & independent QA at various stages of documentation & data processing
  • Our primary objective is to deliver high quality data, on time, to achieve client’s expectations and to supply a data set worthy of regulatory submission

"Successful track record of 120+ Paper CRF & 75+ eCRF Studies"

CDISC
  • CDISC standards help improve data exchange, increase study efficiency, saves time and speeds up approval and makes standardization possible
  • We have recently embarked upon the creation of a highly specialized team of high-end CDISC statistical programming professionals having a minimum of 10 years of industry experience, and SDTM/ADaM experience from 2010, and overall CDISC exposure for the last 7 years
  • Our professionals have worked in the top 5 Pharma companies for a minimum of 3 years, and are internationally trained. They have worked with globally recognized CROs/ BPOs for at least 8 years
SDTM
  • Domain XPTs
  • Define.xml
  • Reviewer guide - SDRG
  • Open CDISC validation report
  • Annotated CRF
ADaM
  • Input from biostatistician
  • Reviewer guide - ADRG
  • Domain XPTs
  • Open CDISC validation report
ADaM
  • Study Kick-off Meeting
  • Specification preparation as per SDTM and ADaM guideline
  • SAS Programming for conversion of legacy dataset
  • Validation of the developed XPTs using double SAS Programming
  • Open CDISC validation check
Biostatistics
  • Dedicated talent pool of Biostatisticians, Statistical SAS programmers, QA auditors & Report writers
  • Robust IT infrastructure ensures your data security, privacy & uninterrupted services
  • Strong statistical expertise in Phase I-IV studies, patient registry trials, Post-Marketing Surveillance studies and Personal Healthcare studies.
  • Expert Biostatisticians who provide valuable input in sample size computation, study design (Superiority, Non-inferiority, Equivalence), Statistical Analysis Plan (SAP) & interpretation of statistical results in various therapeutic areas like Oncology, Dermatology, Immunotherapy, Cardiology, Diabetology, Psychiatry, and Ophthalmology
  • All the procedures are as per ICH standards, regulatory guidelines and performed in accordance with well-defined SOPs, checklists and documentation
  • Our Statistical SAS Programmers are certified with either Base, Advance or Clinical certification with rich experience in developing safety and efficacy TLFs
  • We are GOLD SPONSOR of CDISC and have a talent pool with rich CDISC-SDTM and ADaM conversion experience
  • Medical writers are proficient in developing CRF, ICF, Study Synopsis, Protocol, Reports & Manuscripts as per client requirement of utmost quality

"Successful track record of 500+ Personal Healthcare Studies & 130+ Clinical Trials Phase I-IV"

kTrialsTM (Proprietary e-clinical suite)
  • kTrialsTM is a proprietary e-clinical suite with EDC, IWRS, CTMS, eTMF & SDTM modules integrated into one software
  • CDASH and SDTM mapping capability
  • Web-enabled Clinical Trial Management System (CTMS)
  • Hybrid capability of conducting Paper as well as e-CRF single & multicentric
  • Electronic Trial Master File (eTMF)
  • IWRS integration
  • User friendly functionality
  • Highly scalable and customizable
  • Internally and third party validation with IQ, OQ & PQ
  • High System Security, Secure role based Access and Authentication
  • Available as SaaS model

"Successful track record of 120+ Paper CRF & 75+ eCRF Studies"

Karmic Lifesciences LLP

Karmic Lifesciences LLP is a new legal entity formed after acquiring the assets from Karmic Labs in July 2014 by Cliantha Research Limited. This acquisition has strengthened Cliantha’s capacity to run all Clinical Data Management projects very efficiently and within the stipulated timelines.

We provide integrated services offerings in the areas of Clinical Data Management, Biostatistics, Personal Healthcare and third party Auditing/Monitoring and Consulting Services.

Our aim is to provide the best services to our sponsors by offering hands-on solutions with the right technology, meticulous planning and seamless implementation. Our Validated Clinical Trial Management System, kTrialsTM provides the platform which is easy to deploy, user-friendly and is a next generation, 21 CFR Part 11, integrated EDC + CTMS + eTMF + SDTM Mapping Tool with a Clinical Data Repository.

Karmic Lifesciences -
a leading Global Data Operations CRO offers –
  • Clinical Data Management
  • Biostatistics & SDTM - ADaM Services
  • Medical Writing
  • kTrialsTM eClinical Suite

"Your trusted partner for all your Data Operation needs"

Experience in different Therapeutic Area: (but not limited)
  • Oncology
  • Respiratory
  • Dermatology
  • CNS
  • Diabetes
  • Women and Men’s health
  • Medical device
  • Ophthalmology

Regulatory Inspections

Last Inspection in Nov 2015
Inspected facility in Nov 2006
Inspected facility in Jan 2009
Last inspection in March 2017
Last inspection in April 2017
Last inspection in March 2013
Inspected facility in July 2013
Last inspected by Ministry of Health of Turkey in April 2013
Last inspection in April 2011