Services


CMIC is a leading Contract Research Organization (CRO) specializing in services for pre-clinical and clinical developments. The company provides cutting-edge capabilities and with expertise from over 30 years of expertise in bioanalytical method development, method validation/qualification and study sample analysis from small to large molecules. As a strategic drug development partner, CMIC helps sponsors to overcome challenges in bioanalysis and biomarkers with expertise, rapid turn-around-time and high quality services.


  • CMIC Small Molecule services

    A Global Contract Laboratory

      Laboratory services including: bioanalysis, biomarkers, CMC, GMP analytical, Nonclinical research/ toxicology

      90,000 ft² of laboratory facilities across US and Japan

      300+ employees

      33 years Bioanalytical leader in Japan

      Serving bioanalytical customers in US for 7 years

  • Laboratory and Service Expansion

    In Spring 2017 CMIC will open our expanded US Lab facility (26,000 ft²) adding immunogenicity and PK testing for large molecules and increasing capacity for biomarker testing, small molecule bioanalysis and sample storage.



Exploratory Biomarkers


CMIC offers custom exploratory biomarker services for development, validation and sample analysis in any matrix or quantity. We make sure biomarker results are accurate and reliable.

  1. CMIC offers a wide array of highly sensitive tools to interrogate targets :
    • Cell culture laboratory
    • Ligand-binding assay platforms
    • Flow cytometry
    • Chromatographic platforms
    • Protein analysis (quantifying and sizing)
    • Hi-throughput gene expression analysis and sequencing
  2. Subject matter experts in Oncology, Immuno-oncology, Immunology, and Neurology make sure biomarker results make sense.
  3. Your primary contact will be the CMIC Principal Investigator (PI) in charge of your study because no one knows your study better than you and the PI. Accordingly, we make sure CMIC PIs are easily accessible by phone or email to discuss your project because good communication is absolutely essential for quality and on-time data.
  4. Method development, validation and sample analysis are performed by the same research analyst to ensure the highest quality data. As an added quality measure, each research analyst is backed-up by a second research analyst who reports to the same PI, attends the internal study kick-off meetings, performs real-time QC at each critical step (e.g. standard spike), and provides added study support as needed to ensure on-time results.
  5. Before ever touching a client study, all research analysts and PIs must prove themselves in terms of lab skills and techniques, as well as demonstrate solid knowledge of the GLPs, procedures and systems and complete months of on the job training. When training is completed, each new research analyst and PI must pass a one week intensive skill assessment of pipetting precision and accuracy across every type of pipette used in the lab.


Large Molecules


CMIC delivers large molecule bioanalysis, immunogenicity and PK testing with higher quality data, with more rapid turnaround and fewer surprises:

  1. CMIC offers a wide range of advanced and highly sensitive instruments.
  2. Subject matter experts in Oncology, Immuno-oncology, Immunology, and Neurology make sure biomarker results make sense.
  3. Your primary contact will be the CMIC Principal Investigator (PI) in charge of your study because no one knows your study better than you and the PI. Accordingly, we make sure CMIC PIs are easily accessible by phone or email to discuss your project because good communication is absolutely essential for quality and on-time data.
  4. Method development, validation and sample analysis are performed by the same research analyst to ensure the highest quality data. As an added quality measure, each research analyst is backed-up by a second research analyst who reports to the same PI, attends the internal study kick-off meetings, performs real-time QC at each critical step (e.g. standard spike), and provides added study support as needed to ensure on-time results.
  5. Before ever touching a client study, all research analysts and PIs must prove themselves in terms of lab skills and techniques, as well as demonstrate solid knowledge of the GLPs, procedures and systems and complete months of on the job training. When training is completed, each new research analyst and PI must pass a one week intensive skill assessment of pipetting precision and accuracy across every type of pipette used in the lab.


Oligonucleotides


Since 2012, we have supported hundreds of studies for oligonucleotide-based drugs, including: qualification, full method validation and GLP sample analysis studies for oligonucleotide-based drugs, in tissue and plasma for preclinical and clinical studies.

  1. We have worked extensively on antisense oligonucleotides including :
    • Methoxy
    • LNA/BNA
    • Deoxy
    • 3’ & 5’ End Modifications
    • Fluoro
  2. We have achieved the following LLOQs per instrument in oligonucleotide bioanalysis:
    • LC-MS/MS (5 ng/mL)
    • LC/UV (1 ug/mL)
    • ELISA (1 ng/mL)
    • LC/FD (5 ng/mL)
  3. Your primary contact will be the CMIC Principal Investigator (PI) in charge of your study because no one knows your study better than you and the PI. Accordingly, we make sure CMIC PIs are easily accessible by phone or email to discuss your project because good communication is absolutely essential for quality and on-time data.
  4. Method development, validation and sample analysis are performed by the same research analyst to ensure the highest quality data. As an added quality measure, each research analyst is backed-up by a second research analyst who reports to the same PI, attends the internal study kick-off meetings, performs real-time QC at each critical step (e.g. standard spike), and provides added study support as needed to ensure on-time results.
  5. Before ever touching a client study, all research analysts and PIs must prove themselves in terms of lab skills and techniques, as well as demonstrate solid knowledge of the GLPs, procedures and systems and complete months of on the job training. When training is completed, each new research analyst and PI must pass a one week intensive skill assessment of pipetting precision and accuracy across every type of pipette used in the lab.


Peptides

  1. CMIC uses AB Sciex Triple Quad 5500 LC-MS (11 instruments) for analyzing peptides. The advantage of using these advanced instruments is the expanded MRM reading allowing us to measure multiple peptides, at faster scan rates and at more accurate levels than other instruments such as API 5000 and API 4000.
  2. Your primary contact will be the CMIC Principal Investigator (PI) in charge of your study because no one knows your study better than you and the PI. Accordingly, we make sure CMIC PIs are easily accessible by phone or email to discuss your project because good communication is absolutely essential for quality and on-time data.
  3. Method development, validation and sample analysis are performed by the same research analyst to ensure the highest quality data. As an added quality measure, each research analyst is backed-up by a second research analyst who reports to the same PI, attends the internal study kick-off meetings, performs real-time QC at each critical step (e.g. standard spike), and provides added study support as needed to ensure on-time results.
  4. Before ever touching a client study, all research analysts and PIs must prove themselves in terms of lab skills and techniques, as well as demonstrate solid knowledge of the GLPs, procedures and systems and complete months of on the job training. When training is completed, each new research analyst and PI must pass a one week intensive skill assessment of pipetting precision and accuracy across every type of pipette used in the lab.


Small Molecules


  1. Small molecule bioanalysis is a well established science, but not all small molecule studies are straight forward – CMIC is a partner that can handle any situation.
  2. Examples of challenging Small Molecule Studies we have supported:

    • Validated single methods with up to 6 analytes
    • Compounds containing radioactive isotopes
    • Compounds that are highly absorbent (non-specific binding) or have poor stability
    • Complex matrices: ocular tissue, brain tissue, human tumor tissue, skin patch
    • Provide prefilled transfer containers to support sample stability at sites
  3. Many CROs rely on an inventory of older, less sensitive instruments while the majority of CMIC instruments are Triple Quad 5500 offering better sensitivity:
  4. Your primary contact will be the CMIC Principal Investigator (PI) in charge of your study because no one knows your study better than you and the PI. Accordingly, we make sure CMIC PIs are easily accessible by phone or email to discuss your project because good communication is absolutely essential for quality and on-time data.
  5. Method development, validation and sample analysis are performed by the same research analyst to ensure the highest quality data. As an added quality measure, each research analyst is backed-up by a second research analyst who reports to the same PI, attends the internal study kick-off meetings, performs real-time QC at each critical step (e.g. standard spike), and provides added study support as needed to ensure on-time results.
  6. Method development, validation and sample analysis are performed by the same research analyst to ensure the highest quality data. As an added quality measure, each research analyst is backed-up by a second research analyst who reports to the same PI, attends the internal study kick-off meetings, performs real-time QC at each critical step (e.g. standard spike), and provides added study support as needed to ensure on-time results.


CMIC Bioanalytical KPIs


Risk management of bioanalytical laboratories primarily includes annual quality audits. However, these audits can only capture a “snapshot” of a lab and only for a limited number of studies. A further risk management strategy is to qualify 3 or more approved lab providers in order to avoid putting “all the eggs in one basket”. The limitation of this approach is that it only spreads risk but does not reduce it, furthermore it sacrifices greater savings and process efficiencies that could be gained by consolidating bioanalytical outsourcing to 1 or 2 providers. In contrast, the Late Stage Drug Development Industry users and providers rely heavily on key performance indicators (KPIs) not only as proactive risk management tools but also for bench marking to drive process improvement in providers.

At CMIC we provide Bioanalytical KPIs to clients so that they can:

  • Assess their studies against the entire portfolio of CMIC regulated studies
  • Compare lab performance over time (and even between other labs)
  • Quickly assess highly sensitive measurements of key lab processes from training, analysts’ skill levels, equipment maintenance, workloads to study complexity.
  • Monitor lab performance at regular intervals (e.g. Quarterly)