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  • Remote SDV/SDR: Alternatives To Redact/Fax

    As part of their risk-based monitoring strategy, many sponsors and CROs are using remote techniques to conduct source data review and verification (SDR and SDV).The best implementations out there actually streamline activities at both ends, both for sponsors/CROs and for study sites.

  • Accelerating Drug Development with Translational Imaging - Infographic

    This infographic illustrates the next generation of breakthrough therapeutics, while accelerating drug development with translational imaging.    

  • Dermal Toxicology: A Multifaceted Approach To Meet Today’s Research Needs

    Developing a dermal NCE generally follows the same path as other small molecule NCEs administered orally or systemically, except that the dermal route is used in a non-rodent model.

  • Imaging And Analysis Of A High Density Cell Migration Assay

    Complex biological or environmental signaling events can lead to cell migration, the movement of cells from one location to another. The migration of cells commonly occurs during both normal biological processes such as the development of an organism or marking pathological events such as cancer metastasis. Automated processes in higher density formats improve throughput greatly increasing the usefulness of performing migration assays at a larger scale. This study evaluated the use of a high density cell exclusion assay in 384- well format for investigation of cell migration using a cell line stably expressing green fluorescent protein (GFP).

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  • PBT2 Recommended For Orphan Designation In Europe

    Prana Biotechnology is pleased to announce the European Medicines Agency’s Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending designation of PBT2 for the treatment of Huntington disease as an orphan medicinal product to the European Commission (EC)



Anti-Human Fas for Induction of Apoptosis

IPO-4 is an IgM monoclonal antibody for the induction of apoptosis in Fas expressing human cells...
Control GMP Content And Prevent Revenue Loss In Life Sciences Manufacturing

Control GMP Content And Prevent Revenue Loss In Life Sciences Manufacturing

Life sciences organizations face more pressure than ever to run efficient, uninterrupted manufacturing production at the lowest possible cost. To stay compliant with government regulations, quality and manufacturing organizations must precisely follow Good Manufacturing Practices (GMP) standardized processes and maintain an associated document control process that adheres to those requirements.

Deviations Management Software

Deviations Management Software

The TrackWise by Sparta Systems Deviations Management solution allows a broad range of deviations to be tracked and managed from initial inception, through investigation, root cause analysis through to the execution of corrective and preventative actions (CAPAs) and subsequent change controls.
Quantim Mass Flow Controller

Quantim Mass Flow Controller

Quantim Mass Flow Controller was designed specifically for development of new medicines, including genes in biotech applications that require tight control of gas...
Tech Transfer / Scale-Up Management

Tech Transfer / Scale-Up Management

The Challenge A new customer was having critical quality compliance issues with another CMO. They contracted Patheon to manufacture their sterile lyophilized drug product which was marketed globally, but had only previously been manufactured in the United States.

Array-Pro Analyzer

Array-Pro Analyzer

The Array-Pro Analyzer automates grid, subgrid and spot finding for microarray analysis.
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Introduction to Biostatistics: Collecting and Summarizing Data

May 28, 2015
1pm-3pm EDT, Online Training

Pediatric Clinical Trials: Special Considerations and Requirements

June 1, 2015
2pm-3:30pm EDT, Online Training

FDA GMP Inspections – Proven Preparation & Survival Techniques

June 2, 2015
1pm-2:30pm EDT, Online Training

Cost-Efficient/Cost-Effective Validation Protocols

June 3, 2015
1pm-2:30pm EDT, Online Training
More Upcoming Courses