Scientific

Accelera’s Scientific services deliver core experimental and analytical expertise to generate high-quality, translational data on compound pharmacology, efficacy, and safety. This umbrella encompasses advanced in vivo and in vitro modeling, detailed pathology evaluations, biomarker discovery/validation, and specialized immunotoxicity assessments.

Anatomic Pathology

  •  Accelera provides expert anatomic pathology as part of comprehensive preclinical safety assessment programs

  • Board-certified pathologists perform detailed necropsies, tissue processing, histopathology, and peer review in GLP-regulated studies

  • Identifies compound-related changes, target organ toxicity, and mechanisms across rodents and non-rodents

  • Correlates macroscopic and microscopic findings to support risk evaluation and IND/CTA submissions

  • Integrates with other toxicology endpoints for robust, regulatory-ready data packages

  • Leverages decades of experience to ensure high-quality interpretation and consistency in oncology and other therapeutic areas

  • Accelera’s clinical pathology services analyze hematology, clinical chemistry, coagulation, and urinalysis in preclinical studies
  • Detects early biomarkers of organ toxicity, inflammation, or physiological impact in multiple species
  • Supports dose selection, reversibility assessment, and species translation in GLP-compliant programs
  • Integrates seamlessly with anatomic pathology and toxicokinetics for holistic safety profiling
  • Uses state-of-the-art instrumentation and species-specific reference ranges to generate reliable data
  • Contributes to complete IND-enabling packages recognized by FDA, EMA, and other authorities
  • Accelera identifies, validates, and implements biomarkers for efficacy, target engagement, and toxicity monitoring
  • Offers advanced assays (ELISA, multiplex, genomics, proteomics) to detect organ injury early in preclinical models
  • Bridges nonclinical to clinical translation, enhancing proof-of-concept and de-risking decisions
  • Supports safety assessment in small molecules, biologics, and cell-based therapies
  • Enables sensitive detection before histopathological changes, optimizing study design and regulatory strategy
  • Draws on Accelera’s oncology expertise and integrated development programs for tailored biomarker solutions
  • Accelera designs and executes disease-relevant efficacy models, with strong focus on oncology proof-of-concept
  • Includes xenograft, syngeneic, transgenic, and induced models to evaluate therapeutic potential and PD markers
  • Integrates PK/PD/efficacy data to define therapeutic windows and support candidate progression
  • Tailors models for small molecules, biologics, biosimilars, and advanced modalities
  • Provides reproducible, clinically relevant results to reduce attrition and inform IND strategies
  • Combines efficacy testing with preliminary safety readouts in streamlined programs

Strategic​

Accelera’s Strategic services focus on planning, coordination, and collaboration to optimize program design, mitigate risks, and ensure efficient regulatory progression. This umbrella includes expert guidance on safety planning, full project oversight, and strategic alliances, enabling clients (especially small/mid-size biotech and pharma) to navigate complex IND-enabling pathways with confidence and speed.

Safety & Regulatory Strategy
  • Accelera develops customized nonclinical safety and regulatory strategies aligned with ICH, FDA, EMA, and global guidelines
  • Performs gap analyses, designs optimized IND/CTA-enabling programs, and prepares regulatory documentation
  • Advises on species selection, study duration, endpoints, and SEND data requirements
  • Supports pre-IND meetings, scientific advice, and interactions with health authorities
  • Optimizes timelines and mitigates risks for seamless progression in small and mid-size pharma/biotech programs
  • Accelera’s dedicated project management coordinates multidisciplinary preclinical programs from early safety to full IND packages
  • Oversees timelines, budgets, milestones, vendor performance, and cross-functional teams
  • Ensures GLP compliance, data integrity, and clear sponsor communication
  • Manages complex studies across species, routes, and modalities for efficient execution
  • Delivers audit-ready packages on schedule, supporting over 300 global clients
  • Accelera excels in strategic partnering with biotech, pharma, academics, and non-profits worldwide
  • Matches specialized capabilities (e.g., unique models, regulatory expertise) to client needs
  • Facilitates alliances, MSAs, data integration, and collaborative workflows
  • Enables flexible resourcing, risk-sharing, and accelerated development for innovative modalities
  • Builds long-term relationships, with track record of over 25 integrated programs

Operational

Accelera’s Operational services ensure data integrity, compliance, and seamless submission readiness through specialized support functions. Positioned atop the block, these enable high-quality execution and long-term archival of GLP studies, supporting global regulatory acceptance.

QA (Quality Assurance)
  • Accelera’s independent QA unit oversees GLP compliance across all preclinical activities
  • Conducts facility/process inspections, protocol/SOP reviews, critical phase audits, and data/report verification
  • Identifies deviations, assesses impact, and verifies CAPA implementation
  • Maintains master schedules, training records, and audit trails
  • Builds regulatory trust in data reliability for IND submissions and inspections
  • Accelera maintains GLP-compliant archiving for raw data, specimens, slides, reports, and electronic records
  • Offers secure, climate-controlled storage with full chain-of-custody and audit trail
  • Preserves histological slides, wet tissues, and digital files for long-term retrieval and inspections
  • Supports regulatory audits, historical reference, and potential re-evaluation
  • Ensures data integrity throughout the product lifecycle for client confidence
  • Accelera supports SEND (CDISC Standard for Exchange of Nonclinical Data) for electronic regulatory submissions
  • Generates, validates, and conforms datasets for toxicology, safety pharmacology, and related studies per SENDIG
  • Structures data using SDTM domains (TX, PC, PP, MI, OM, BW) for FDA/EMA review efficiency
  • Ensures traceability, interoperability, and compliance in IND/NDA packages
  • Integrates SEND preparation into GLP programs for seamless global submissions