Clinical Technical Focus

• Clinical site biopsy management.

  From when the tissue leaves the patient, we manage the rest.
  • Manuals.
  • Training of site personnel.
  • Monitoring of each and every biopsy and procedure at the sites, either in person, or remotely via live videoconferencing.

• Frozen sample shipments.

  International shipping of frozen samples needs focused expertise to provide assurance of sample integrity. AGADA closely manages the shipping from source to end, and ensures that tissue integrity.

• Frozen sections.

  AGADA staff are trained experts at frozen sections for histology and immunohistochemistry. We can do the assays on site, or ship slides (or tissue aliquots) to preferred vendors.

• Biomarkers.

  We generate top quality, robust RNA, protein, and DNA biomarker data in support of your clinical trial outcomes.

• Surrogate biomarker in context of use of accelerated approvals.

  FDA requires robust validations of bioassays used as the primary outcome in accelerated approvals.  AGADA has a series of off-the-shelf pre-validated bioassays reviewed by FDA in support of dystrophin as a surrogate outcome. For these and other bioassays, we are happy to develop an individualized Sponsor-specific biomarker validation plan.

• Post-marketing bioassays.

  AGADA has developed a LIPS assay covering the entire dystrophin protein that can be utilized in post-marketing safety surveillance for treatment-emergent anti-dystrophin antibodies.