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Contract Services

 

HemoGenix® Contract Research Services

HemoGenix Contract Research Services 

 

Reliable Consultation

We are committed to providing our clients with the most trusted and highest quality research. As part of our consultation with our clients, we provide the best possible advice and alternatives in order to achieve the goals of the study.

Cost-Effective Contract Service Capabilities

The list below demonstrates our capabilities. Many of these are proprietary in vitro assay platforms designed and developed by HemoGenix®. We are also cognizant of being as cost-effective as possible and will provide alternative proposals, if requested.

Customized Workflow

At HemoGenix®, no two studies are the same. Every study is customized and tailored for specific client goals. We also work closely with other CROs to expand in vivo pre-clinical animal studies to in vitro testing that can provide considerably more information than would otherwise be obtained.

 

The following is an example of our workflow.

  • A nondisclosure/confidentiality agreement (NDA/CDA) will be signed.
  • A quote will be prepared and revised to suit the client's budget.
  • All studies are QA audited throughout the workflow regardless of whether thay are GLP or non-GLP compliant.
  • Prior to the start of any study, a detailed Study Plan will be prepared by the Study Director for the Study Monitor's / Sponsor's approval.
  • Sponsor ships test articles for study.
  • The target cells/tissues for the study will be procured.
  • The study will be initiated upon arrival of the target cells or tissues.
  • Most in vitro studies are completed within 7-14 days.
  • Phase I Report is usually provided within 4 - 7 business days after study completion.
  • Phase II Final Report is generated after all comments and corrections have been made and the final QA audit performed.
  • Once the Phase II Report has been delivered, the study will be terminated.
  • Three copies of the complete study will be held in the HemoGenix® archives.
Study Parameters

Whether GLP or non-GLP, the study parameters are chosen with the sponsor to provide clear and comprehensive data.

  • Number of compounds or test articles.
  • Dose range and number of doses (usually 6-12) to be tested (if applicable).
  • Number and type of reference, positive and/or negative controls.
  • Primary assay(s) to be used and add-on assays (if required) to be performed.
  • Type and number of cell populations to be tested.
  • Type and number of species to be tested. 
  • Type of test compound addition (if applicable):
    • Timed pre-culture addition.
    • Direct addition for culture duration.
    • Timed post-culture addition.
  • Special culture conditions, if required.
  • Sample analysis / curve-fit analysis, type and number of EC/IC values (if relevant) and statistics (if applicable).
  • GLP / non-GLP/QA audit.

NOTE: Unless otherwise required by the Study Monitor/Sponsor, HemoGenix® will perform all compound studies blind. 

Deliverables

Most in vitro studies are completed within 7-14 days. Draft reports are sent within 5-7 business days. Unless otherwise requested, the following deliverables are provided.

  • Study plan prior to initiating the study. The study plan must be accepted by the Study Monitor/Sponsor prior to starting the study.
  • Continuous up dates regarding the study.
  • QA auditing.
  • Phase I Draft Report providing the text version of the study and results, including:
    • Protocol,
    • IC/EC values,
    • Ranking with respect to compound IC/EC value(s), species, cell types (where applicable),
    • Estimation of in vitro to in vivo starting doses (where appropriate).
    • Results in graphical form.
  • Phase II Final Report and Study Termination including:
    • All corrections and comments provided by the Study Monitor.
    • All aspects in Phase I Draft Report.
    • QA manager audit certification.
    • All raw data provided as hard- and electronic copy.