Biometrics

Biometrics is one of the centres of excellence that Cliantha research excels into. With more than 14 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
17
Code Angelo Projects
26
Professionals

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 like Rave®, Inform®, Medrio®, , Acceliant, Omnicomm, SAS PheedIT, ClinTrial & our propiratory software Code Angelo
  • 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 disorders
  • Dermatology
  • Endocrine and Metabolism
  • Nervous system disorders
  • Oncology
  • Respiratory
  • Vaccine
  • Gastroenterology
  • Haematology
  • Hepatobiliary disorders
  • Immune system disorders
  • Ophthalmic
  • Psychiatric disorders
  • Rheumatology
  • Infections and infestations
  • Infectious diseases
  • Injury, poisoning and procedural complications
  • Musculoskeletal and connective tissue disorders
  • Renal and urinary disorders
  • Reproductive system and breast disorders

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

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

Our biostatisticians implement technical knowledge to support you throughout the entire clinical development process. Team has experience in all phases of research and development from pre-clinical analysis to clinical and post-marketing services across various therapeutic areas..

Experience

115
Phase II-IV Studies in 20 Therapeutic Categories
600
Consumer Research Studies
324
CDISC Submissions
55
Professionals
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:

CDISC data sets deliverables for submissions to regulatory markets such as USFDA

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

Producing randomization schedules

Statistical Analysis Plan (SAP) with mock-shells

Statistical programming of tables, figures and listing

BE & Clinical trial study design and Statistical inputs in Protocol

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 Personal Healthcare studies. Study design (Superiority, Non-inferiority, Equivalence),
  • 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
  • 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 to ensure 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