Biometrics

Biometrics is one of the centres of excellence that Cliantha Research excels into. With more than 19 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

290

Studies

110

Indications

70000

Patients

200

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

7000

BA/BE studies

195

Late Phase Studies

1450

CDISC studies

Services:

Sample size estimation

Study design, Statistical inputs in protocol-CRF

Randomization schedule

Statistical Analysis Plan (SAP) with mock-shells

TFL programming and validation

CDISC data submission (SDTM, ADaM, Define.xml)

BDRM & Interim analysis

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 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