Biometrics

Biometrics is one of the centres of excellence that Cliantha research excels into. With more than 15 years of experience, we have been successful in carving the niche for ourselves.

With more than 100 trained professionals, biometric team provides efficient and cost effective outsourcing solutions for Clinical Data Management, Biostatistics & Programming and CDISC.


  • Data Management
  • Biostatistics and Programming
  • CDISC

Data Management

Experience

99
Studies
84
Indications
42859
Patients
18
Code Angelo Projects

Expertise

  • 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
  • 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
  • High quality data, on time delivery,

Therapeutic Experience

  • Cardiac
  • Dermatology
  • Endocrine and Metabolism
  • Nervous system
  • Oncology
  • Respiratory
  • Vaccine
  • Gastroenterology
  • Haematology
  • Hepatobiliary
  • Immune system
  • Ophthalmic
  • Psychiaty
  • Rheumatology
  • Infections and infestations
  • Infectious diseases
  • Injury, poisoning and procedural complications
  • Musculoskeletal and connective tissue
  • Renal and urinary
  • Reproductive system and breast

Rich experience in every phase of Data Management

START-UP PHASE
  • Case Report Form Designing (pCRF / eCRF)
  • Data Management Plan Development
  • Edit check specifications
  • External Data Agreement plan (e.g. Lab, ECG, Device data etc)
  • Data Management Project Management
  • CRF Completion Guideline
  • Database Design Specification
  • Annotated CRF (aCRF)
  • Database Designing
  • Database Programming
  • User Acceptance Testing (UAT)
  • Database Live
CONDUCT PHASE
  • CDISC-CDASH / SDTM compliant data collection and processing
  • Electronic Data Capture in EDC studies
  • Double Data Entry in Paper studies
  • Discrepancy Management (System/ Manual)
  • Self-Evident Corrections
  • Tracking & Closing Queries
  • SAE data reconciliation
  • External data reconciliation and cleaning e.g. Lab, Device Data etc.
  • SAS system based data review
  • Lab normal management
  • Medical Coding using MedDRA and WHODrug Global
  • Data Export and Transfer
  • Standard report for project management
  • Ad-Hoc report
CLOSE-OUT PHASE
  • Database quality audit
  • Independent review for each document
  • Quality Control on all data processing steps
  • Quality Assurance
  • Database soft lock/ hard Lock/ Interim lock

CDM tools

Data management team have experience of working on various CDM tools

CodeAngelo ® - Cliantha’s Proprietary Tool

and many more

CodeAngelo ®

Cliantha's proprietary Clinical Data Management platform: CodeAngeloTM - 21 CFR part 11 compliant system
Diversified Features

Instant Validation

Role based secure access

Dynamic data entry & review workflow

Mid study changes Manage amendments and any mid study change instantly.

Standard, Ad-Hoc Reports & Role based Dashboard

Integrated Query Management

Medical coding Interface - Auto & Manual with MedDRA, WHODrug Global

Rapid CRF design

Local lab management Effectively manage local and normal lab ranges

Complete Reporting More then 30 reports are available along with ad-hoc query based report

24x7x365 Helpdesk Support

Differentiating Primers

Advanced Performance Reporting, and Analytics for Senior Management

Flexible licensing and SAAS (Software as a Service)

Intensive Back up Solution

Highest Level of Security, Reliability & Scalability

Biostatistics and Programming

Experience

115
Phase II-IV Studies in 20 Therapeutic Categories
600
Consumer Research Studies
324
CDISC Submissions
5751
BA/BE studies
31
FIH studies
27
SAD/MAD Studies
24
Drug-Drug interaction
23
PK/PD Studies
15
Food effect studies
50
Tobacco Research Studies

Services:

BE & Clinical trial study design and Statistical inputs in Protocol

Sample size determination ( nQuery/Pass/SAS – software)

Producing randomization schedules

Statistical Analysis Plan (SAP) with mock-shells

Data submission using CDISC format / Sponsor specific requirement

TFL Development and Validation using SAS software

BA-BE / Phase 1

  • Pharmacokinetic and Pharmacodynamic Bioequivalence studies
  • SAD & MAD studies
  • Vasoconstriction and Dose response (DRC) studies for topical dermatologic corticosteroids
  • In-Vitro population bioequivalence (PBE)
  • Adhesion, Irritation and Sensitization (HRIPT) analysis
  • Statistical analysis of Carcinogenicity studies
  • Bootstrap analysis
  • Cut point, Sensitivity & Specificity analysis
  • Equilibrium & Kinetic Binding data

Phase II- IV

  • Strong statistical expertise in Phase I-IV studies, patient registry trials, Post-Marketing Surveillance studies and Claim studies.
  • Statistical input to study design and selection of primary endpoint(s)
  • Various therapeutic areas like Oncology, Dermatology, Immunotherapy, Cardiology, Diabetology, Psychiatry, Ophthalmology etc.
  • Well-defined SOPs, checklists and documentation driven processes.
  • Team of certified SAS programmers and Biostatisticians

Consumer Research

Safety Testing Efficacy Studies Personal/baby Hygiene OTC Products Cosmetics/Beauty Care
Irritation (PIPT, HRIPT, Cumulative irritation, Scalp & Ocular irritation) Expert graders Antiperspirants
Deodorants
Acne, Cold sore, Wound healing, Pain Makeup, Cleansing Products, Moisturizers
Sunscreen safety Physician evaluations Liquid & Bar Soap Eye & Foot care Lip/Nail/ hair care
Oral Tolerance Bioinstrumentation/
digital photography
Shampoos, Diapers/Wipes Nutritional, Vitamin, Weight management Age spot, Cellulite
Comedogencity Consumer questionnaires Rash cream/lotion Dandruff/Seborrehic Dermatitis, Lice Line and wrinkle reduction
Photo Allergy / toxicity Smoking cessation Sanitary Lubricants skin elasticity

Biostatical tools

  • Phoenix® WinNonlin®
  • SAS®
  • PASS (Power Analysis & Sample Size)
  • nQuery
  • CDISC Services

CDISC

Expertise

  • Dedicated & experienced team Team of 30 professionals to provide CDASH & CDISC submission package Technical review team ensures accurate interpretation of SDTM / 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

Services

  • Strategic Consulting
  • CDISC Standards Implementation
  • Standardizing legacy data models and Data conversion
  • Training of CDISC standards and Governance

Ongoing study data into CDISC compliant:

  • CDASH Compliance
  • SDTM and ADaM
  • Open CDISC Validation (Pinnacle 21 validator)
  • Define.xml/Define.pdf

CDISC Deliverables

SDTM
  • Domain XPTs
  • Reviewer
  • Annotated CRF
  • Define.xml
  • Define.pdf
  • CDISC validation report
ADaM
  • Input from biostatistician
  • Domain XPTs
  • Reviewer guide – ADRG
  • CDISC validation report
  • Define.xml
  • Define.pdf