Solutions:

We are typically called upon for implementations, technology support and domain consulting in clinical trials space. Our previous assignments with major clients and solutions include:

• Developing in house tools and solutions in data migration and integration of disperse data management applications for a Multinational Contract Research Organization
• Implementing Clinical Data Management System and Document management System for a Specialty Hospital with Clinical Research facilities
• Developing a electronic data capture (EDC) solution and integration with electronic diaries (monitoring devices), Implementation of DataFax system for a Pharmaceutical Company with Clinical and Preclinical Research initiatives
• Consulting Pharmaceutical manufacturer for the Bioavailability and Bioequivalence studies for :
  
  
• Technological support and training to the resources in Clinical Data Management Activities for pharmacokinetic and phase III clinical trial studies
• Preparation of eCDT documents adhering to the CDISC standards
• Data mining and document solution for Medical Writing activities in accordance with the SPL guidelines of FDA
• A tool for loading laboratory results and data in batch format
  
  
• Implementing Technology for Clinical Data Management Activity ( Package implementation), A tailor made solution for document management for local Ethics committee (IRB) : A midsize CRO specializing in outsourcing clinical trial activity
• Data and image management solutions for a private Radiological Clinic
• Product development in Clinical domain(drug safety and coding) for IT product development company in US
• Helped with validation of the computer systems and CDM package (Oracle Clinical 4.5), Installation of Drug Dictionaries (MedDRA and WHO-drug), training resources in adverse events coding and reporting through Oracle Forms and Reports : Highly specialized mid size CRO with KMO arm
• Developing and planning ODCs(off shore development center) for Clinical Data Management and sourcing technological resources in Asia pacific region ( India and China): Full Service Contract Research Organization and a Life Sciences Organization

Recent / ongoing specialized Consulting Assignments and Solutions

• Global Drug Safety Reporting solution for a pharmaceutical marketing company and Sponsor (one of the top five pharma companies)
• “Pharmacovigilance and Adverse Event reporting” training for resources of a major CRO operating in Asia pacific
• “Introduction and training of Medical coding in Clinical Trials” for resources of a BPO in healthcare space firm specializing in Medical Transcription and Coding
• Clinical Supply management solution for a global pharma packaging company
• Setting up the Clinical Data Management group of a major Life Sciences Research Organization in India.
• Support to the Off shore Development Center of a major IT player and a pharmaceutical company for Clinical Data Management and Biometrics