Clinical Research Area Expertise
Clinical Research Area Expertise
Expert Solutions in Globally Significant Clinical Research Areas
Synexa is a globally recognized solution provider in key clinical research areas, with our core expertise being drawn from our teams’ vast experience in the field of immunology, making us well suited to providing unparalleled insight into the immunological underpinning of disease and the activity of novel therapeutics.
The field of immunology is key to understanding the development of most diseases. In addition, it is a field which has opened up the scope of therapeutics and given much promise for improving global health and lessening the disease burden in key therapeutic areas such as oncology.
Our scientists are well versed in the field and have pioneered key immunology-based investigative techniques, providing quality, clinically-relevant translational research data to our clients, collaboratively studying the effects of the therapeutic across each aspect of the biological continuum from DNA to Tissue.
- Autoimmune diseases are among the most complex of diseases to treat owing to their often heterogeneous nature and clinical trials require long-term and in-depth monitoring of the immune system and related cells.
- Synexa successfully incorporates proven biomarker strategies and investigative techniques to provide clinical trial data that is robust and relevant, giving our clients the necessary insight to guide decision-making at each stage of pipeline development.
- Cancer remains one of the most complex and difficult to treat diseases and is a leading cause of death worldwide. Advances in the understanding of the immune systems holds great promise for treatment solutions.
- Our validated and physiologically-relevant assay formats are developed to the highest standard and according to regulatory guidelines to assess:
- Assessment of target engagement quantifies the effects of the therapy on the immune system, providing integral early insight into the therapeutic’s activity, saving time and money on molecules with less than optimal engagement.
- Data obtained to quantify the effects of the immune system on the malignancy is best studied in an integrated manner by utilizing biomarkers from across the biological continuum, from DNA through to Tissue.
Infectious diseases are recognized as one of the most pressing risks to global health, with an increasing number of significant outbreaks occurring in recent years, making vaccine development a core area of clinical research.
Key to successful vaccine development is a thorough understanding of the immune system and its activity during the course of vaccine activity. We apply assessment assays and immune monitoring technologies appropriate for every stage of the vaccines development.
- Synexa Life Sciences has validated an innovative, market-leading SARS-CoV-2 Serology Assay, suitable for a wide array of high-throughput clinical research applications.
- The ELISA-based SARS-CoV-2 serology assay has been developed for the detection of several antibody isotypes, including IgG, IgM and IgA as well as the determination of the neutralization potential of the sample by detecting the presence of neutralizing antibodies which prevent the binding of the SARS-CoV-2 spike protein to the ACE2 target receptor.
We specialize in the development and validation of assays according to a sponsor’s priorities and requirements on any Biosimilar, BioBetter or NBE molecule.
We have validated assays for the assessments of high-profile molecules such as, among others, Adalimumab, Pegfilgrastim and Ustekinumab.
We use innovative, industry-proven and trusted technology platforms to ensure we provide only best data for your purpose.