A personalized approach to consumer health, clinical trials, bioanalytics, and product development.

Clinical Services

Aegis is fundamentally changing the way consumer and patient health is analyzed and managed. We provide clinically-actionable information and bioanalytics that helps healthcare providers, pharmaceutical, biotech, and nutrition companies develop innovative new products and treatments tailored to every individual, leading to better outcomes.

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The Aegis Advantage

The Aegis Advantage

Complete solution provider

  • Comprehensive genomics and proteomics testing capabilities
  • Full-service clinical trial laboratory support

Experienced

  • Clinical experience and disease-specific expertise
  • Key Opinion Leader network and several collaborations with leading centers

Quality

  • Performance metrics of lean Six Sigma
  • Controlled environment (CAP, ISO, and GCP-compliant)

Aegis meets all your needs.

 

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Discovery & Development

Discovery & Development

Aegis helps pharmaceutical, biopharmaceutical, and biotech companies by providing services along the entire discovery and development pathway. With several years of experience as a global contract laboratory service organization, Aegis provides integrated solutions along the entire clinical trial continuum. We have established several outsourcing models to adapt to different client profiles and can assist clients by identifying the best solution to fit their needs.

 

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Capabilities

Capabilities

Aegis offers a broad menu of clinical services on multiple technology platforms and a dedicated staff committed to delivering excellence in science, technology, and customer service. 

Bioanalytical services for pre-clinical and clinical studies

  • Method development
  • Method validation
  • Lead optimization studies
  • Pharmacokinetic (PK) analysis
  • Bioavailability studies 
  • Bioequivalence studies
  • Dose formulation analysis

Small molecule bioanalytical services

  • Quantitative bioanalytical LC-MS/MS
  • Rapid discovery phase bioanalysis

Large molecule bioanalytical services

  • Immunochemistry services
  • Quantitative immunoassays
  • Immunogenicity assays
  • Biomarker assays
  • Cell-based neutralization assays
  • Ligand-binding assays

Bioinformatics

  • Process large and complex data sets
  • Perform statistical analysis, study design, pathways analysis, biological interpretation, and reporting
  • 21 CFR Part 11-compliant data tracking and storage

Drug substance, impurity, and product testing

  • Finished product testing and certification for foods, supplements, or pharmaceuticals
  • Verify the quality of products

Identify the presence of contaminants

  • Anabolic agents and steroids
  • Anti-estrogens
  • Aromatase inhibitors
  • Beta-2 agonists
  • Beta-blockers
  • Diuretics and masking agents
  • Hormone and metabolic modulators
  • Narcotics and cannabinoids
  • Stimulants

Tampered pharmaceutical testing or solid dose drug identification

  • Verify if products were tampered with or altered
  • Confirm the identity of unknown pills, tablets, and syringes
 

 

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Technology

Technology

Aegis offers access to state-of-the-art genomics capabilities in a dedicated 6,000 square foot BioPharma laboratory.

Flow Cytometry/Cellular Analysis

  • Identification of immunological signatures of disease progression and/or therapeutic efficacy
  • Monitor residual disease

Cytogenetics/Chromosomal Analysis

  • Assist in diagnosis and provide prognostic information

Fluorescence in situ Hybridization/Karyotyping

  • Detect disease-specific abnormalities
  • Apply standard FISH or array comparative genomic hybridization (aCGH) technologies

Gene expression and genotyping

  • Quantitative Polymerase Chain Reaction (qPCR)
  • Nanostring

Gene Mutation Analysis

  • Identify drug resistance/toxicity
  • SNP analysis
  • Next generation or Sanger sequencing
  • Custom panel development

Gene Rearrangement Analysis

  • Determine B-cell or T-cell clonality

Circulating Tumor Cell (CTC) Detection

  • Monitor treatment efficacy

Enzyme-Linked Immunosorbent Assays (ELISA)

  • Assess breadth, magnitude and specificity of the immune response

LC-MS Analysis/Proteomics

  • Protein identification, quantification and analysis
  • Custom protein profiling

Quantitative Assays

  • Pharmacokinetic (PK) Assays
  • Toxicokinetic (TK) Assays

Sample prep and extraction

  • Isolation of low abundant species
  • Enrichment of DNA, RNA, and proteins

 

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Supplies & Logistics

Supplies & Logistics

Managing the complex logistics of delivering your clinical trial supplies to your participants is a costly and time-consuming task that can distract you from crucial drug development endeavors. Partnering with Aegis allows you to leverage the logistical prowess of a laboratory that already handles collection supply delivery and sample receipt of more than 2,000 biological specimens every day, 365 days a year. Our long-standing relationships with recognized leaders of logistics solutions, combined with more than 3,500 square feet of in-house storage facilities for materials and biological specimens, ensure you will receive best-in-class supplies and logistics support for your clinical trials at an exceptional cost.

Sample kit creation

  • Kit materials are stored, assembled, and recycled on-site
  • Custom kit design and building services available for any specimen type
  • Low cost and quick turn-around

Logistics and fulfillment

  • Substantial discounts on local, regional, and global shipping
  • Logistical management of kit assembly, specimen handling, manifest generation, shipping and receiving, and transit monitoring
  • Priority customs clearance
  • Around the clock monitoring with proactive notifications of expected delays

Specimen storage

  • Bio-repository storage facililty available on-site
  • Walk-in freezers and refrigerators with ample storage and temperature monitoring
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Certifications and Accreditations

Certifications and Accreditations

Aegis operates four laboratories, all of which meet the rigorous requirements of proficiency testing and on-site reviews to maintain the proper certification and accreditation from various regulatory organizations, such as:

  • American Association for Laboratory Accreditation (A2LA) in accordance with ISO/IEC 17025
  • Clinical Laboratory Improvement Amendments (CLIA)
  • College of American Pathologists (CAP)
  • Good Clinical Practices (GCP) compliant
  • United States Drug Enforcement Administration (US DEA)
  • Various state departments of health, including:
    • California
    • Florida
    • Kentucky
    • Maine
    • Maryland
    • New Jersey
    • New York
    • Oklahoma
    • Pennsylvania
    • Rhode Island
    • Tennessee
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Get Started

Get Started

The next step to improving your clinical trial is to get in touch. We'd love to discuss your needs and work together to find the best custom solution to bring your product to market.


biopharma@aegislabs.com

 

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