Clinical Research

From India, to the world, Izenbio has always believed in one philosophy- Global Reach with Local Expertise. With strong experience of conducting clinical trials in regions like US, Western and Eastern Europe, Asia-Pacific etc, Izenbio has the global reach and capability to conduct studies and navigate regulatory requirements of IND, ANDA, WHO and various Local regulatory agencies. Backed by strong clinical and therapeutic expertise, we take a highly flexible and customized approach to clinical research by listening closely to our customers and tailoring our services to their unique needs and projects, from select stand-alone services to full-service international studies.

A snapshot of our clinical trial projects by therapeutic areas is mentioned below:

Izenbio's Therapeutic Experience
Therapeutic Area Phase I Phase II Phase III Phase IV
Diabetics      
Anti-infective      
Opthalmology      
Vaccine
Dermatology      
Neurology      
Psychiatry      
Medical Device    
Oncology    
Gynecology      
Gastroenterology      
Details of each study as are follows: Diabetics
Description Indication No. of Sites Patients Geographical Coverage Service Provided
Phase III Type II Diabetes Mellitus 12 201 India Full service
Phase III Type II Diabetes Mellitus 6 96 India Full service
Infectious Diseases:
Description Indication No. of Sites Patients Geographical Coverage Service Provided
Phase III Urinary Tract Infection 2 200 India Full service
Ophthalmology:
Description Indication No. of Sites Patients Geographical Coverage Service Provided
Phase IV Allegic Conjunctivitis 20 300 India Full Service
Phase IV Dry Eye 20 300 India Full Service
Phase I Wet AMD & Diabetic Retinopathy 1 50 Bangladesh Full Service
Immunology:
Description Indication No. of Sites Patients Geographical Coverage Service Provided
Phase III Measles 9 600 India Full service
Phase III DTP 8 306 India Full service
Phase III DT 3 100 India Full service
Phase III Tetanus 5 600 India Full service
Phase III Tetanus 1 120 India Full service
Phase IV DTP-Hb-H1b 40 640 India Full service
Phase II/III Japanese Encephalitis 8 456 India Full service
Phase II/III DTPH 1 33 India Full service
Phase I Measles 1 180 India Clinical Operations & Vendor management
Phase I Swine Flu 3 100 India Clinical Operations
Phase I Meningococcal 3 100 India Full Service
Phase III Varicella 4 100 India Full service
Dermatology:
Description Indication No. of Sites Patients Geographical Coverage Service Provided
Phase III Psoriasis 15 600 India Full Service
Phase III Rosacea 10 450 India Full Service
Neurology
Description Indication No. of Sites Patients Geographical Coverage Service Provided
Phase IIb Acute Ischemic Stroke 10 90 India Full Service
Phase II Parkinson's disease 7 60 India Full Service
Psychiatry:
Description Indication No. of Sites Patients Geographical Coverage Service Provided
Phase II Schizophrenia 19 228 India, US, Philippines and Malaysia Full Service
Medical Devices:
Description Indication No. of Sites Patients Geographical Coverage Service Provided
Phase II Venous leg ulcer 4 40 India Full Service
Phase III Venous leg ulcer 5 25 India Full Service
Phase III Venous leg ulcer 9 100 India Full Service
Oncology:
Description Indication No. of Sites Patients Geographical Coverage Service Provided
Phase IV Non small cell lung cancer 4 19 India Full service
Phase IV Early Breast Cancer 4 13 India Full service
Phase IV Metastatic Colorectal Cancer 3 16 India Full service
Gynecology:
Description Indication No. of Sites Patients Geographical Coverage Service Provided
Phase III Dysmenorrhea 14 480 India Full Service
Gastroenterology:
Description Indication No. of Sites Patients Geographical Coverage Service Provided
Phase III Duodenal ulcer 30 600 India Full Service
CDM Services

Feasibility Studies and Site/Investigator Identification and Selection

Identifying a suitable investigator/site will be one of a key aspect in success of any clinical study. With more than 15 years of experience we are well connected with investigators and KOLs. Our extensive database has over 700 investigators from various therapeutic areas. At Izenbio we carefully evaluate the investigator site through our custom designed feasibility questionnaire.


The key elements we consider during our evaluation process are:

  • Investigator experience and time for clinical research
  • Study team members experience and training
  • Study specific site facilities
  • Patient population and recruitment strategies
  • Previous and competing clinical studies
  • Timeline for EC approvals and CTA execution
  • Archiving and sample retention policies

Site Monitoring

We offer high quality monitoring services. Our CRAs/PMs are experienced and ACRP certified professionals. The clinical monitoring services include:

 

  • IRB/IEC application preparation, submission and approvals
  • Site specific regulatory binder creation and maintenance
  • Training of site personnel
  • Site initiation visits
  • Clinical site management
  • Interim monitoring/co-monitoring visits
  • Site close out visits
  • CRF retrieval
  • Query management
  • Study materials supply management
  • Vendor supply management

Patient Recruitment and Retention

We are committed to ensuring the success of your trial. Our Patient Recruitment Services Group can serve as an integral part of your trial team and identify and manage the most appropriate vendors for your needs. We can develop the best patient recruitment and retention strategies to help you meet key milestones for your program and serve as a liaison to a number of media outlets and Izenbio validated vendors.

Project Management

We offer a dedicated project manager for your clinical study. Our PMs are well trained and experienced in various therapeutic areas like Oncology, Gastroenterology, Cardiology, Nephrology, Neurology, Neuro Psychiatry, Infectious Diseases and Endocrinology.

The project manager will track all key activities of the study and provide timely update to our sponsors. Our PMs are trained to focus on quality aspects, timely and within budget delivery of a project. They are responsible, flexible and problem solving professionals. Our key success in project management is the PM shall function as an extension of your clinical development team.

Key skill sets of Izenbio's PM:

  • Highly experienced in various therapeutics areas
  • Establish and maintain clear communication path throughout the study
  • Flexible and problem solving professionals

Medical Monitoring

Subject safety and wellbeing is the primary focus of a clinical study. Our experienced group of physicians will serve as a link between our sponsors and the investigative sites. We offer safety monitoring and medical management support to your clinical studies. Our team of physicians will leverage their clinical experience and practical knowledge in conduct of a clinical study. Our medical monitors shall provide:

  • Protocol and study specific training to the investigators
  • Response to subject evaluation criteria questions
  • Safety monitoring – AE and SAE management
  • Support in regulatory agency representation

Quality Assurance

Quality control steps are built into all of our processes. We have an independent quality assurance department that engages ongoing quality and compliance assessments of all of the services we offer. In particular, we regularly conduct internal process audits to ensure compliance with good clinical practices, standard operating procedures, vendor qualifications, and commitments to clients – all for the purpose of continuously insuring the quality of our services remains at the highest level.

Our Quality Assurance and Compliance Services are focused on three main areas of audits:

  • Project audits, e.g. investigator files/site audits, trial master file audits, database audits, statistical report audits, clinical study report audits and regulatory submission audits
  • Process audits
  • Vendor audits

Copyright © 2014 izenbio.com. All rights reserved.