eClinical

Proprietary tools enhancing the data accuracy & timely delivery

21 CFR part 11 compliant system
Cliantha's Proprietary Clinical Data Management Platform

Successfully completed 200+ studies for various regulatory agencies

Diversified Features
1

Rapid eCRF design using Global Library

2

CDISC & CDASH compliant database design

3

Seamless Data Entry

4

Integration of third party tools

5

Integrated query management

6

Medical Coding Interface Auto & Manual coding with MedDRA & WHODrug

7

Efficient mid-study change management

8

Standard & ‘On-Demand’ Reports

9

Role based secured access

10

Cloud based data hosting & strong data backup

11

24 x 5 Helpdesk System

Differentiating Primers

Advanced Performance Reporting, and Analytics for sponsors/ key stakeholders

Flexible licensing and SAAS (Software as a Service)

Strong data security & privacy through cloud based data hosting & validated systems.

Minimal annual maintenancemakes it cost effective

>1700 users globally have used CodeAngelo tool

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.

Cliantha operates 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

  • eLearning 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 & Development Ecosystem

1

Approved New/ Revised SOP

2

Training team trained by author

3

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

4

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

5

Design Team converts into Training Content

6

Content deployment to E-learning System

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
1

E-Learning System Controlled user access is provided to trainee through user name and password by system admin

2

Trainee log in to e-learning system through account created by system Admin

3

Reporting in charge assigns role and upload CV & certificates

4

Reporting in-charge approves Training schedule

5

Based on the role assigned system auto generates training Schedule: SOPs, On job training, Manual and Guideline

6

Trainee agrees and e-signs on the role assigned

7

Training is conducted through E-learning modules followed by online assessment (Designed by qualified trainers)

8

Certificate of completion is awarded

9

Post successful training, trainee is enrolled as employee