Therapeutic Expertise
 

Our growing THERAPEUTIC EXPERTISE provides clients with clinical trial services including drug development planning, cGMP contract manufacturing partner Facility, strategic assessment, submission support, and dossier planning, execution and maintenance. Qualtran staff will conduct regulatory agency meetings and provide agency liaison services for domestic and international pharmaceutical companies. With staff on the ground in India, UK and USA, we bring our clients a strong understanding of global regulatory requirements including ICH guidelines and CTD submissions.

Qualtran was established with the belief that with streamlined processes and state of the art technology, any project will result with the same outcome - “Done right and on time!” Over the last 3 years this idea has proven itself true. Due to repeat business and a knowledgeable staff, Qualtran has developed specific therapeutic expertise and is expanding on it.
Global data management and analysis have become increasingly complex. Fully integrated databases, reports and data submissions are needed in order to meet critical milestones leading up to regulatory submission. Qualtran is organized to meet those needs. Clients can select the services they require within the complete management and coordination of clinical programs for regulatory submission.

Specific Clinical and Regulatory Therapeutic Expertise:

Cardiovascular Disease:
Qualtran has worked in a variety of cardiovascular diseases studies and has applied technology to the successful control of patient screening, validation before randomization and continued compliance during therapy. Qualtran has conducted studies in the following areas:

  • Hypertension
  • Arrhythmias
  • Congestive Heart Failure
  • Thrombosis
  • Deep Vein Thrombosis

    HIV/ Infectious Disease:
    Qualtran has worked in various capacities to conduct studies in patients with Infectious Diseases. Our office in India is a platform for conducting HIV studies. Our staff is experienced in the management of vaccine and therapeutic studies. Difficult-to-find populations are usually more readily available for study in India. Qualtran also provided management services as well as clinical monitoring, remote study management and data management and analysis services in the following areas:

  • Viral Pneumonia
  • Human Immunodeficiency Virus (HIV)
  • Hepatitis C
  • SARS

    Internal Medicine:
    In difficult-to-find patient population studies, Qualtran works with clients to over-enroll sites and control costs using technology to manage data from those sites who are actively screening and enrolling patients into the study.

  • Osteoarthritis
  • Rheumatoid Arthritis

    Oncology:
    Qualtran is currently conducting studies in Oncology using technology to manage the process of data collection and quality of life assessments in the areas of
  • Breast Cancer
  • Prostate Cancer

    Hematology:
    Qualtran has worked with clients to identify sources for difficult-to-find patients for clinical studies; we have used a combination of technology and regional solutions to find patients and manage costs.

  • Hemophilia
  • Von Willebrand’s disease

    Other Development Services:

    Regulatory Services

  • Preparation of global product-specific regulatory strategies and product development plans
  • Regulatory guidance at all stages of product development
  • Planning, preparation, submission, and maintenance of regulatory documents
  • Interactions with regulatory authorities regarding project specific issues
  • Coordination, preparation and participation in meetings with regulatory authorities regarding product development issues.
  • Pre-IND, Pre-IDE Meetings
  • End-of-Phase 2 Meetings
  • Pre-NDA, Pre-PMA Meetings
  • Regulatory liaison activities
  • Regulatory guidance at all stages of product development
  • Interactions with regulatory authorities to coordinate inspection activities
  • Maintenance and archiving of clinical regulatory documents
  • Support to product labeling activities

    Clinical Study Management

  • Site solicitation, qualification and management
  • Investigator Meeting Organization and Conduct
  • Clinical Study Monitoring
  • Medical Monitoring
  • Pharmacy and Un-blinded Drug Management
  • Remote Study Management Using Electronic Data Management and Monitoring Tools
  • Real-Time Reporting, Visit Report and Monthly Status Report

    Data Management

  • Case Report Form (CRF) design and printing
  • Database design and data entry
  • Query management
  • Medical coding
  • Database Consolidation
  • Electronic Data Transfer
  • Status reports

    Statistics and Programming

  • Sample size calculations
  • Treatment randomization and code break envelopes
  • Statistical analysis of clinical PK/PD endpoints
  • Meta/integrated analysis
  • Summary tables, figures and listings
  • Integrated Safety Summary (ISS)/ Common Technical Document (CTD) tables
  • Statistical reports
  • Ad hoc data summaries

    Pharmacokinetics/Pharmacodynamics

  • Rapid interim PK analysis
  • Noncompartmental PK and PD analysis
  • Toxicokinetic analysis
  • Bioanalytical data review
  • PK reports/contributions
  • PK/PD modeling and simulation

    Medical Writing

  • Fully integrated clinical and PK/PD reports for electronic submission
  • Marketing/regulatory documents — writing and editing
  • Protocol preparation
  • SOP writing
  • Investigator drug brochure preparation and update


    Program Management

  • Project Management
  • Management and coordination for study programs in which clinical aspects are conducted at centers worldwide
  • Clinical monitoring, data management, biostatistics, programming and reporting of every study provided in one agreed-upon format
  • Creation and management of global clinical pharmacology databases
  • Overall program timelines driven by regulatory submission

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