eClinical

Proprietary tools enhancing the data accuracy & timely delivery


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, WHODD

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

CodePv

Coming up Shortly

CodeKrisna

Learning is life long process & when learnt through innovative concepts, one tends to grasp things better. Cliantha's foundation is based on the employee training. We are amongst the few CROs to have a dedicated Training Department to design and deploy training content for the employees. Cliantha’s elearning system is defined by specific functions and for various competency levels. The Learning Management System is a robust learning technology, custom designed for current clinical research industry needs. The training content is deployed in short modules with animations and videos. There are provisions for online assessments and needs-based reports.

We operate with an integrated training, learning and performance support function that employs a variety of instructor-led and/or technology-enabled modules. These training modules are designed to facilitate employees’ advancement of their knowledge and skills required for effective performance as a professional.


Objectives

Uniformly train all new as well as existing employees and other contractual/ consultant staff

Increase understanding and awareness of employees about working standard at Cliantha

Consistency and synchronization in the work procedure

Avoid confusion; Ensure role clarification; Minimize errors

Features

  • E-learning system is defined by profile based training specific to each function and various competency levels
  • Targeting core competency by strategic training programs
  • Basic entry level
  • Compliance training programs
  • Training content is made in-house and deployed in short modules with animations and videos
  • Provision for online assessments and need based reports
  • Courses available for training areas like in-house systems (SOPs), regulatory guidelines (GCPs, GLPs, ICH, EMA, WHO etc.), manuals (safety, quality), site specific training
  • Study specific training programs at site level, if required

Training Process

Generation of Training Content:

Approved New/ Revised SOP

Training team trained by author

Training information formulated to include process videos, documentation examples etc.

Working on content along with designing question bank, Regulatory guidelines GCPs, GLPs & other modules

Design Team converts into Training Content

Content deployment to E-learning System

Training

New Joinee training
  • Trainer assisted one to one sessions
  • Assessment pattern: Random questions from bank; Immediate display of correct answers, on each incorrect attempt
  • Average training period ~ 15 days
Ongoing training for employees
  • Mass training sessions for revised/new SOPs, regulatory guidelines, Annual GCP/GLP; followed by assessments
  • Assessment pattern: Random questions from bank; Immediate display of correct answers, on each incorrect attempt
  • Documentation of ongoing external trainings

Training Flow

E-learning system (web-based): Controlled user access is provided to trainee through e-signatures & assigned rights by system administrator

Trainee logs into the e-learning system account crated by system administrator

Department Head assigns roles, uploads CV & Certificates

Trainee agrees & e-sign on the role assigned

Based on the assigned role, the system auto generates Training schedule: SOPs, Manuals, guidelines, Practical trainings

Department Head approves training schedule

Training is conducted through e-learning modules, followed by assessment (by designated qualified trainers)

Certificate of completion is awarded

Post successful training, candidate enrolls as an employee

CodeLisa

CODELISA is a software which provides end-to-end e-clinical solutions for process included in clinical trial. It is a closed system that helps in organizing, handling, implementing, monitoring and scrutinizing activities and data related to trial in observance to the protocol and regulatory authority’s need.

CODELISA is a web based system designed to streamline processes included in clinical trial by replacing traditional paper-based process with electronic techniques.

CODELISA provides complete solution starting from volunteer/subject registration till report compilation. It is fully validated, compatible with 21 CFR, GCP requirements and other applicable regulatory requirements.

CODELISA, Electronic data capture system (EDC) mainly consists of different modules (but not limited to) like Admin, Volunteer management system, Project management & Protocol writing, Clinical, Sample inventory, Report compilation & report writing modules and CDISC Tool. All the modules are linked internally with each other and are interfaced with other software/devices as applicable for the necessary data capture and its management.

Overview for all the modules is mentioned below:
  • Admin module provides administrative functionality like user management, role management, master management, and password policy & authentication process.
  • Volunteer Management System module:
    • Registration provides all functionality related to biometric verification and registration of volunteers' information.
    • Screening provides functionality related to screening activities like Demographic details, Medical screening record, Lab sample collection, Lab parameter evaluation etc.
  • Project Management & Protocol writing Module is for Project/ study management & protocol preparation within the System.
  • Clinical module provides facility to make the CRF/Study CRF. User can also make study/project specific rule according to protocol. It also provides facility regarding protocol specific training, IMP dispensing label generation, PK sample label generation, study conduction with data review process. It allows real time data collection through barcode scanning and accelerates the data collection to avoid sample swapping during conduction.
  • Sample inventory module contains sample handling process like sample pick up, centrifugation, sample separation, sample storage, sample re-arrangement, sample shipment, Sample tracking & sample movement etc.
  • Review Process and Audit Trail: System have facility for real time data monitoring with review process. It also has facility to generate DCF for discrepancy and resolution process. System has facility to capture audit trail for each and every activity with date and time stamp.
  • Report compilation & Report writing module facilitate to extract all study data to prepare report and also have facility to export all subjects’ CRF for Final e-CTD submission.
  • CDISC tool provides facility to map CRF data with SDTM domains and variables and data extracting facility for CDISC output preparation.