HemoGenix® Contract Research Services

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.

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.

• High-throughput screening
• Primary cell systems, cell lines and tumor cells
• Set price and full service comparative toxicity screening and compound ranking
• Stem cell toxicity
• Bone marrow toxicity and stem cell hematotoxicity
• Immunotoxicity
• Mesenchymal cell toxicity
• Hepatoxicity
• Cardiotoxicity
• Neurotoxicity
• Renal toxicity
• Skin toxicity
• Intestinal toxicity
• Genotoxicity
• Nanoparticle toxicity panel testing
• Mechanism of Action (MOA)
• Drug-drug interaction and combination therapy
• Biologics, small molecule and drug functionality and potency testing
• Stem cell potency and quality testing for cellular therapeutics
• Customized basic research on several biological systems

Customized, Full-Service Workflow

Usually, no two studies are the same. At HemoGenix®, every study can be 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 customized, full-service studies are QA audited throughout the workflow regardless of whether they 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 5 - 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.

Rapid Toxicity Workflow

Our Rapid Toxicity Workflow is, in many respects, similar to the Customized, Full-Service Workflow, except that a full report and QA audit is not provided. This means that the cost of the study will be significantly less expensive. This may be more preferable for early stage toxicity detection. However, the protocol, raw data and graphical data provided in a single Excel Workbook are the only deliverables.

A Study Plan will be provided and must be accepted by both parties. No interpretation of the data and no conclusions are provided. In addition, a Rapid Toxicity Workflow will not include a QA audit of the study or results.  

Rapid Tox Screening Workflow 

A Rapid Tox Screening Workflow is similar to a Rapid Toxicity Workflow, but is specific for high-throughput cytotoxicity screening. A Rapid Tox Screening Report is provided as an Excel Workbook with raw and graphical data. No text report, no interpretation and conclusion and no QA audit is performed. However, like the previous workflows, a Study Plan is provided prior to performing the study and must be accepted by both parties.

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. 

Please Note: All studies performed by HemoGenix^® include a Study Plan which must be accepted by signature by both parties. The Study Plan will include the starting date for the study. This date is often the day on which cells and/or tissues will arrive at the HemoGenix® facility. In the majority of cases, the Study Start Date cannot be changed. If a study requires testing one or more test articles, these must be provided to HemoGenix^® by the Sponsor at least 5 days prior to the Study Start Date. Failure to provide the test article(s) at the required time will result in postponement or cancelation of the study and additional costs. 

Unless specifically requested by the Sponsor, quotes for HemoGenix® Contract Services will be provided as both a Customized Full-Service Study and a Rapid Toxicity Testing Quote. Where available, a Set Cost Toxicity Screening Quote will also be provided.

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.

Customized, Full-Service Study Quote

A Customized, Full-Service Study Quote includes a Full Report and QA audit of the study, results and report. 

Study plan prior to initiating the study. The study plan must be accepted by the Study Monitor/Sponsor prior to starting the study.

• Continuous updates 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. 

Rapid Toxicity Testing Quote

To provide a more cost-effective contract service, a Rapid Toxicity Testing Quote will be included in all quotes, unless a Customized, Full-service Study Quote is specifically requested by the Sponsor. 

A Rapid Toxicity Testing Study does not include a text report (no Phase 1/Draft Report and Final Report) and no QA audit of the study results or report is provided.  

Instead, a Rapid Toxicity Testing Study includes single Excel Workbook with the Protocol, raw data and graphical data (where appropriate). No conclusions or interpretations are provided. As a result, a quote for a Rapid, Toxicity Testing Study will be significanly more cost-effective and the study will be terminated more rapidly than a Full Report/Service Study. 

High-Throughput Toxicity Screening Quote

A Set Cost Toxicity Screening Quote is very similar to a Rapid Toxicity Testing Quote, except that the former is not customized, but provides specific toxicity testing capabilities at a set price. An example of this is our ComparaTOX™ HT Platform, where the response of compounds in multiples of 5 are tested on specific tissues for a set price. Like the Rapid Toxicity Testing Quote, protocol, raw data and graphical results are provided in an Excel Workbook. Not Text Report (Draft or Final Report) and no QA audit is provided. In addition, no interpretation of the results and no conclusions are provided.