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Accelera GmbH

Accelera GmbH is a CRO whose strengths lie in high-quality, GLP-compliant preclinical studies and an integrated platform that supports both small molecule and biologic drugs. Here, we introduce Accelera GmbH's features and examples of disease models.

Features of Accelera GmbH's Contract Research Services for Non-Clinical Studies

Integrated technology platform supporting a wide range of modalities

Accelera is,A comprehensive non-clinical testing platform capable of supporting both small molecule drugs and biologicsWe offer integrated toxicology, safety, and efficacy testing, providing consistent support from the early stages of drug discovery to the IND application phase. We also handle advanced modalities such as cell and gene therapy, and our strength lies in generating highly accurate data by utilizing diverse research models and translational research.

High-quality testing system compliant with GLP and international standards

The facility is in full compliance with GLP (Good Laboratory Practice),AAALAC accreditation obtainedWe conduct tests using a workflow that aligns with ICH and OECD guidelines, ensuring scientifically valid and highly reproducible data. Furthermore, we have a rigorous quality control system based on years of operational experience and a commitment to animal welfare, earning us high praise for both reliability and ethical practices in non-clinical testing.

Support for Global Regulatory Compliance and Reduction of Development Risks

including the US FDA and the European EMAProviding a data package that is accepted by regulatory authorities in various countriesWe have strengths in preclinical drug development. By designing and consulting on studies that take regulatory requirements into account, we minimize the risk of amendments or re-testing at the time of IND/CTA applications. We also offer consistent support from scientific advice to application strategy, contributing to the optimization of development time and costs by generating high-quality data that supports development decision-making (Go/No-Go).

Example of a disease model owned by Accelera GmbH

CDX Model (Cell Line-Derived Xenograft)

The CDX model is a tumor model created by transplanting standard human-derived cancer cell lines into immunocompromised mice. Since tumor growth can be observed with high reproducibility,Rapid screening of pharmacological effects of anticancer drugs and molecular targeted drugs.It is suitable for use. Accelera also offers it as one of the main in vivo cancer models, and it is widely used for preclinical efficacy evaluation, such as tumor growth assessment and dose-response analysis.

Humanized Models

Humanized models are models where human immune cells (such as PBMCs and hematopoietic stem cells) are transplanted into mice, thus reconstructing the human immune system. They can reproduce human-specific immune responses in vivo and are useful for evaluating biopharmaceuticals such as immune checkpoint inhibitors and antibody drugs. At Accelera,Applications combined with CDX models, etc.It is also possible. It is used for the analysis of drug efficacy and mechanisms of action, including the interaction between tumors and the human immune system.

Non-clinical study examples from Accelera GmbH

functioning as a strategic partner

Detailed information regarding non-clinical trial cases was not found. The official website features testimonials from CEOs of biotech companies. They praise Accelera not just as a CRO, but as a strategic partner. By addressing complex regulatory requirements and streamlining toxicity evaluation and pharmacokinetic studies in the preclinical phase,Significantly accelerate the transition of new drug candidates to clinical trials (Phase I)It is stated that they achieved this. Adherence to the timeline and a flexible trial design based on scientific knowledge were directly linked to resource-limited emerging biotech's funding and development progress.

Source: Accelera GmbH Official Website
https://www.accelera.org/

Accelera GmbH Company Information

Address Milan, Italy
Tel +39 340 2108530
Website https://www.accelera.org/
3 Recommended Contract Research Organizations for Non-Clinical Studies
— by Target goal and Expertise

In drug discovery, the quality and efficiency of non-clinical studies have a direct impact on clinical success rates, development costs, and overall length of time required in R&D. In recent years, there has been more demand for clinically relevant data, globally accepted reliability, and accurate early-stage screening. Thus, it is more important than ever to select the right CRO (Contract Research Organization) for strategic approach.
In this article, we highlight three CROs with proven technical capabilities, expertise, and long standing track records. These are our TOP 3 choices based on their capabilities and the specific target goals of the researchers for their non-clinical studies.

Pharmacology (Efficacy) Studies
Replicate unknown pathological models and
Discovery to clinically oriented drug evaluation
SMC Laboratories, Inc.
SMC Laboratories, Inc.
Reference: SMC Laboratories official website (https://www.smccro-lab.com/jp/)
  • SMC Laboratories has established a disease models using patented mouse technologies. The company has established proprietary pathological models—particularly in liver disease and fibrosis—and continues to expand their approach across a wide range of models in cancer, inflammation, and metabolic diseases.
  • From exploratory research to clinically oriented efficacy evaluation, SMC offers customized study designs, dosing strategies, and evaluation analysis tailored to each project. Their collaborative approachallows researchers to discuss and refine study plans together with SMC’s expert scientists.

  • With flexible small-scale study options and strong technical support, SMC Laboratories is an ideal partner for start-ups, biotech ventures, and academic institutions alike.
Safety Studies
Comprehensive Safety Evaluation for FIH Applications
labcorp
(Labcorp Drug Development)
labcorp
Reference: labcorp official website (https://jp.labcorp.com/)
  • labcorp provides a fully integrated GLP testing system aligned with international regulatory standards, including FDA, EMA, and PMDA requirements. All studies are conducted under ICH-compliant quality assurance, making it ready for data submission.
  • The company has extensive expertise in long-term toxicity studies such as Segment I–III reproductive and carcinogenicity studies, as well as 2-year chronic toxicity assessments.
  • labcorp’s comprehensive approach enables sponsors to efficiently outsource the entire preclinical package from toxicology, toxicokinetic (TK), and safety pharmacology study design to execution. This accelerates a path to First-in-Human (FIH) trials. For most of the global drug developers, this all-in-one service structure minimizes cost, risk, and expedite the time before advancing to clinical phase.
Pharmacokinetic (PK/PD) Studies
High-Precision Bioanalysis for Clinically Predictive PK/PD Evaluation
PhoenixBio
PhoenixBio
Source: PhoenixBio Official Website (https://phoenixbio.co.jp/)
  • PhoenixBio offers pharmacokinetic and hepatic metabolism studies using their proprietary PXB-mouse®, a humanized-liver chimeric mouse model. This platform enables the acquisition of data with high clinical correlation in ADME, drug–to-drug interaction studies, bridging the gap between preclinical and clinical stages.
  • With advanced LC-MS/MS-based bioanalysis, PhoenixBio provides aseamless workflow from plasma concentration measurement and metabolite identification to quantitative validation.

  • The company offersan integrated evaluation analysiscovering pharmacokinetics, hepatotoxicity, and safety with flexibility to accommodate complex modalities such as oligonucleotide and middle-molecule therapeutics. For compounds where hepatic metabolism is a development bottleneck—or where quantitative, reproducible exposure data are critical—PhoenixBio delivers unmatched analytical precision and consistency.

Consult Phoenix Bio for PK/PD analysis with a clinical focus
By region
list of animal models
Expertise & Track Record
3 Recommended CRO for Non-Clinical Studies