DISCOVERY
Medicinal Chemistry, Pharmacology/Biology, and ADME/Tox Screening in NA and China.
DRUG DEVELOPMENT
Strong science driven DMPK, Safety & Toxicology and Clinical organizations that can provide end-to-end development services.
LAB TESTING SERVICES
Regulated (GLP/GMP) Bioanalytical and Analytical Chemistry services to support Safety Tox, and Clinical Studies.
PRODUCT DEVELOPMENT & MANUFACTURING
API Synthesis Formulation and Clinical Trial Material Manufacturing (CTM).
SCIENTIFIC
EXPERTISE
Consultation and collaboration with our clients to solve complex drug development challenges by leveraging our strong scientific expertise.
HARMONIZED GLOBAL QUALITY STANDARDS
Application of consistent high-quality standards, systems, and process across all sites globally ensures data integrity for regulatory review,decision support, and adjudication.
LEVERAGING STATE OF
THE ART TECHNOLOGY
Apply our deep understanding of laboratory science with our best-in-class platforms to develop solutions to complex scientific challenges.
Even the bitterest fruit has sugar in it.
– Terry a O’Neal
The trees that are slow to grow bear the best fruit.
– Molière
TABLE EXAMPLE
| Gene | Protein Variant | Expected AF | Observed AF | Required Depth |
|---|---|---|---|---|
| AKT1 | E17K | 5.05 | 3.9% | 460 |
| BRAF | V600K | 3.8% | 2.6% | 485 |
| BRCA2 | K1691Nfs*15 | 5.6% | 4.5% | 320 |
| EGFR | G719S | 5.3% | 5.6% | 492 |
| EGFR | L858R | 3.0% | 2.2% | 747 |
| EGFR | T790M | 4.2% | 4.6% | 377 |
| FBXW7 | S668Vfs*39 | 5.6% | 6.2% | 431 |
| FLT3 | P986Afs*27 | 5.6% | 3.9% | 340 |
| FLT3 | I836 | 5.0% | 4.5% | 376 |
| GNA11 | Q209L | 5.6% | 3.7% | 553 |
| ∆IDH11 | R132C | 5.0% | 5.2% | 410 |
| JAK2 | V617F | 5.0% | 3.2% | 338 |
| KRAS | G12A | 5.0% | 3.9% | 335 |
| Gene | Protein Variant | Expected AF | Observed AF | Required Depth |
|---|---|---|---|---|
| AKT1 | E17K | 5.05 | 3.9% | 460 |
| BRAF | V600K | 3.8% | 2.6% | 485 |
| BRCA2 | K1691Nfs*15 | 5.6% | 4.5% | 320 |
| EGFR | G719S | 5.3% | 5.6% | 492 |
| EGFR | L858R | 3.0% | 2.2% | 747 |
| EGFR | T790M | 4.2% | 4.6% | 377 |
| FBXW7 | S668Vfs*39 | 5.6% | 6.2% | 431 |
| FLT3 | P986Afs*27 | 5.6% | 3.9% | 340 |
| FLT3 | I836 | 5.0% | 4.5% | 376 |
| GNA11 | Q209L | 5.6% | 3.7% | 553 |
| ∆IDH11 | R132C | 5.0% | 5.2% | 410 |
| JAK2 | V617F | 5.0% | 3.2% | 338 |
| KRAS | G12A | 5.0% | 3.9% | 335 |
Our bioanalytical team has been developing methods and analyzing bioanalytical samples for more than 20 years to our sponsors globally. We have over 450 scientists in multiple facilities located in the USA, Canada, Europe and China. Our senior scientists average 10 – 15 years in complex drug development and many come from leading Pharmaceutical companies. Over 70% of our scientists hold advanced degrees.
Our bioanalytical team has been developing methods and analyzing bioanalytical samples for more than 20 years to our sponsors globally. We have over 450 scientists in multiple facilities located in the USA, Canada, Europe and China. Our senior scientists average 10 – 15 years in complex drug development and many come from leading Pharmaceutical companies. Over 70% of our scientists hold advanced degrees.
SCIENTIFIC
EXPERTISE
Consultation and collaboration with our clients to solve complex drug development challenges by leveraging our strong scientific expertise.
HARMONIZED GLOBAL QUALITY STANDARDS
Application of consistent high-quality standards, systems, and process across all sites globally ensures data integrity for regulatory review,decision support, and adjudication.
LEVERAGING STATE OF
THE ART TECHNOLOGY
Apply our deep understanding of laboratory science with our best-in-class platforms to develop solutions to complex scientific challenges.
Scientific Expertise
Consultation and collaboration with our clients to solve complex drug development challenges by leveraging our strong scientific expertise.
Harmonized Global Quality Standards
Application of consistent high-quality standards, systems, and process across all sites globally ensures data integrity review, decision support, and adjudication.
Leveraging State of the Art Technology
Apply our deep understanding of laboratory science with our best-in-class platforms to develop solutions to complex scientific challenges.
SCIENTIFIC
EXPERTISE
Consultation and collaboration with our clients to solve complex drug development challenges by leveraging our strong scientific expertise.
HARMONIZED GLOBAL QUALITY STANDARDS
Application of consistent high-quality standards, systems, and process across all sites globally ensures data integrity for regulatory review,decision support, and adjudication.
DISCOVERY
Medicinal Chemistry, Pharmacology/Biology, and ADME/Tox Screening in NA and China.
DRUG DEVELOPMENT
Strong science driven DMPK, Safety & Toxicology and Clinical organizations that can provide end-to-end development services.
LAB TESTING SERVICES
Regulated (GLP/GMP) Bioanalytical and Analytical Chemistry services to support Safety Tox, and Clinical Studies.
PRODUCT DEVELOPMENT & MANUFACTURING
API Synthesis Formulation and Clinical Trial Material Manufacturing (CTM).
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Our bioanalytical team has been developing methods and analyzing bioanalytical samples for more than 20 years to our sponsors globally. We have over 450 scientists in multiple facilities located in the USA, Canada, Europe and China. Our senior scientists average 10 – 15 years in complex drug development and many come from leading Pharmaceutical companies. Over 70% of our scientists hold advanced degrees.
Our bioanalytical team has been developing methods and analyzing bioanalytical samples for more than 20 years to our sponsors globally.
We have over 450 scientists in multiple facilities located in the USA, Canada, Europe and China. Our senior scientists average 10 – 15 years in complex drug development and many come from leading Pharmaceutical companies. Over 70% of our scientists hold advanced degrees.
Even the bitterest fruit has sugar in it.
– Terry a O’Neal
The trees that are slow to grow bear the best fruit.
– Molière
- Bioanalytical
- Modalities
- Genomics
- Central Lab Services
- MC Biologics Gene & Cell Therapy
PRODUCT DEVELOPMENT
& MANUFACTURING
- Formulation Development
- Clincal Trial Material
- Commercial Manufacturing
- Analytical Testing
DISCOVERY
Medicinal Chemistry, Pharmacology/Biology, and ADME/Tox Screening in NA and China.
DRUG DEVELOPMENT
Strong science driven DMPK, Safety & Toxicology and Clinical organizations that can provide end-to-end development services.
LAB TESTING SERVICES
Regulated (GLP/GMP) Bioanalytical and Analytical Chemistry services to support Safety Tox, and Clinical Studies.
PRODUCT DEVELOPMENT & MANUFACTURING
API Synthesis Formulation and Clinical Trial Material Manufacturing (CTM).
DISCOVERY
Medicinal Chemistry, Pharmacology/Biology, and ADME/Tox Screening in NA and China.
DRUG DEVELOPMENT
Strong science driven DMPK, Safety & Toxicology and Clinical organizations that can provide end-to-end development services.
LAB TESTING SERVICES
Regulated (GLP/GMP) Bioanalytical and Analytical Chemistry services to support Safety Tox, and Clinical Studies.
PRODUCT DEVELOPMENT & MANUFACTURING
API Synthesis Formulation and Clinical Trial Material Manufacturing (CTM).
DISCOVERY
Medicinal Chemistry, Pharmacology/Biology, and ADME/Tox Screening in NA and China.
DRUG DEVELOPMENT
Strong science driven DMPK, Safety & Toxicology and Clinical organizations that can provide end-to-end development services.
LAB TESTING SERVICES
Regulated (GLP/GMP) Bioanalytical and Analytical Chemistry services to support Safety Tox, and Clinical Studies.
PRODUCT DEVELOPMENT & MANUFACTURING
API Synthesis Formulation and Clinical Trial Material Manufacturing (CTM).
1,800
Employees
Worldwide
20+
Years of Successful Growth
25
Sites in North America, AsiaPac, & Europe
35+
Awards Received for CRO Leadership
Types of Studies
- First-in Human (SAD/MAD)
- Drug-Drug Interaction
- Bioavailability/Bioequivalence
- Food Effect
- Cardiac Safety (TQT)
- Human Mass Balance (hAME)
- Absolute Bioavailability (ABA)
- Vaccine
- Proof of concept
Delivery Systems
- Oral
- Injectable (IV, IM, SC)
- Inhalation
- Intranasal
- Topical, Patch
- Suppository
Specialized Areas of Expertise
- Controlled Substances
- Topical Patch (Skin assessments)
- Antidote/Reversal
- Cognitive Impairment Assessments
- Mass Balance (hAME) Studies
Dedicated On-Site Recruitment Team & Extensive Subject Database:
- Pre-Qualified Subjects
- Healthy Subjects
- Targeted Subject Populations
Therapeutic Area Experience
- Cardiovascular
- Metabolic Syndrome
- Infectious Disease
- Inflammation
- Virology
- Allergy
- Dermatology
- Gastrointestinal
- Pulmonary/Respiratory
- Analgesia