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Clinical Trials to Contract Research Organizations

Clinical research and development especially in technically demanding areas such as drug discovery and biotech R&D is a fast-emerging field.

Clinical Research and Drug trial Services

A Contract Research Organization handles work right from designing the clinical drug trials, monitoring and managing, collecting data, handling adverse events, Data Management to statistics .

Clinical research and Data Management are the core competencies of a successful Contract Research Organization, thus allowing the parent company to focus on other less time consuming and more strategic processes. Another advantage of using an effective CRO for clinical research services is that it avoids bias that may otherwise creep in to the parent company's research in a bid to validate the data that that it has collected.

Along with fair, accurate and unbiased clinical drug trial conduction, the whole drug delivery process is expedited. Furthermore it has been realized that in addition to Data Management and clinical trial services, attention has now been turned to research and development especially in technically demanding areas such as drug discovery and biotech R&D.

This coupled with the fact that India has always been identified for its expert data analysts, including Ph.D. statisticians, mathematicians, life science experts, biotechnology professionals, pharmacologists, and various other highly qualified professionals make our company a value addition for your clinical research and drug trial and Data Management outsourcing requirement.

Read about Flatworld's scientific KPO for drug discovery here.

Types of Clinical Drug Trial studies conducted by us:

  1. DRUG METABOLISM STUDIES
    • First administration clinical studies
    • Pharmacokinetics
    • Pharmacodynamic studies with regards to multiple routes of entry
    • Pk-Pd Modeling
    • Linearity studies
  2. INTERACTION STUDIES
    • Drug - food interaction Studies
    • Drug - drug interaction Studies
  3. FOOD EFFECT STUDIES
    • Food effect studies
    • Fasting studies
  4. SAFETY STUDIES
    • Safety and tolerability studies
    • Drug/drug interaction studies
    • Rising dose tolerance
    • Chronic dosing
    • Multiple dose and steady state studies
    • Invitro-invivo correlation
    • Hepatic and Renal Impaired studies
  5. DERMATOPHARMACOKINETICS
    • Nutritional and cosmetic studies
  6. BA / BE STUDIES
    • Bioequivalence studies
    • Bio availability Studies

Components of Clinical Drug Trials that we conduct:

Phase I - Clinical Drug Trials

  • Study Protocol with CRF design and review
  • Subject Information and data base build up
  • Informed Consent Services to the subjects
  • Prompt recruitment and screening procedures
  • Collection and processing of specimen samples
  • Transport of specimen samples
  • Recruitment and Training of necessary personnel
  • Dietary services-Uniform diet according to the Protocol
  • Monitoring / Quality Control / QA
  • External / Internal Audits
  • Data Management

Phase II to IV - Clinical Drug Trials

  • All services common to Phase I trial
  • Providing targeted protocol services with focus on clinical trial objective
  • Ongoing clinical trial consultancy with medical, scientific and technical committees
  • Insurance of clinical trials
  • Constant access to patients of various therapeutic areas
  • Establishment of Clinical Research Contact Center, where consultancy with various clinical and scientific professionals will be an ongoing service
  • Analytical clinical data reports-interim and final with availability of all documents in electronic or hard copy forms
  • Drug Shipment and Drug Labeling
  • Continuing interaction with the Ethical and Regulatory committees

Methodology of Clinical Drug Trial services we provide:

1. Product Development and Documentary Services

  • The ability to properly plan prior to the implementation stage is a crucial step in ensuring the long-term success of any clinical drug trial
  • To highlight those potential hurdles to an effective clinical drug trial and to propose stringent remedial measures for the same is essential for smooth implementation
  • Hence prior clinical drug trial consultancy with focus on early development proposals, assessment of service capabilities along with preparatory ethical and regulatory guideline adherence codes is required

2. Patient Recruitment and Retention

  • Selecting study groups appropriate for the required clinical study design is essential to the clinical trial
  • Furthermore avoidance of attrition can be carefully avoided with selection of appropriate vendors. Our recruitment services identifies and serves as a contact specialist for multiple authenticated vendors which coupled with the correct retention strategies will help meet target objectives of the study

3. Clinical Trial and Site Management

  • Our comprehensive team of industry-rich experienced personnel follows your protocol requirements and recommendations to identity and recruit clinical trial sites that provide potential advantages in patient recruitment and technological prowess
  • Individual sites are evaluated in order to meet GCP criteria on quality, staffing and capabilities with extensive development in the area of reduction of intra and inter site variation and bias

Services in this regard include:

  • Site selection and initiation
  • Research site selection and evaluation
  • Site initiation
  • Site set-up and training for Electronic data capture
  • Investigators' meetings
  • Personnel training
  • Site Monitoring
  • Source data validation
  • Data query management
  • Checking internal consistency of CRF data
  • Issuance of Data Alerts to CDM
  • Monitoring of attrition and enrollment rates and patient eligibility criteria
  • Site closure
  • Project Management
  • Research site liaison
  • Tracking CRFs and DCFs
  • SAE/AE collection, evaluation, classification, reporting, and reconciliation;
  • On-site support and Help-desk
  • EDC-Electronic data Capture
  • Comprehensive on-line data validation and adaptable study design for all phases of trials
  • Allows data analysis on an as and when basis-in conjunction with interim and final data reports
  • Electronic transfer of laboratory data using a fully validated Part 11 compliant LIMS system in association with CTLS. (Clinical Trials Laboratory Services)
  • Drug accountability

Read about Flatworld's Scientific KPO for Drug Discovery and Clinical Data Management Services.

For clinical research and Data Management solutions, outsource to us.

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