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| Summary | Atheln provides integrated consulting and strategic development services across product development, CMC, nonclinical, clinical, regulatory affairs, and commercialization for pharma, biotech, and medtech clients. | Premier Research is a global full-service CRO delivering clinical research and development solutions across the complete drug development lifecycle. The organization provides comprehensive capabilities spanning study design, study startup, medical affairs, biostatistics and data management, central monitoring, clinical monitoring and site management, project and risk management, safety and pharmacovigilance, quality and compliance, and medical writing. |
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| Services | - Analytical Method Development & Validation
- Regulatory Affairs
- US FDA Regulatory Strategy
- EU EMA Regulatory Strategy
- Japan PMDA Regulatory Strategy
- Clinical Operations
- Medical Writing
- Translational Research
| - Phase I Clinical Trials
- Phase II Clinical Trials
- Phase III Clinical Trials
- Phase IV / Post-Marketing
- Clinical Operations
- Clinical Trial Services
- Data Management & eClinical
- Biostatistics & Statistical Programming
- Medical Writing
- Pharmacovigilance & Drug Safety
- Central Laboratory Services
- Regulatory Affairs
- US FDA Regulatory Strategy
- EU EMA Regulatory Strategy
- Japan PMDA Regulatory Strategy
- China NMPA Regulatory Strategy
- Translational Research
- GLP Toxicology
- Safety Pharmacology
- In Vitro ADME / DMPK
- In Vitro Pharmacology
- Preclinical In Vitro Studies
- In Vivo PK / PD Studies
- In Vivo Efficacy Models
- Preclinical In Vivo Studies
- Device & Combination Product Services
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| Modalities | - Small Molecule
- Biologics (Other)
- Oligonucleotide
- Radiopharmaceutical
- Peptide
| - Small Molecule
- Biologics (Monoclonal Antibodies)
- Biologics (Other)
- Cell Therapy
- Gene Therapy
- Peptide
- Vaccine
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| Indications | | - Oncology
- Immunology
- Neurology
- Infectious Disease
- Rare Disease
- Dermatology
- Women's Health
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| Locations | Data not yet provided. | - Headquarters, Morrisville, NC, United States
- Southbank, Southbank, VIC, Australia
- Sofia, Sofia, Bulgaria
- Toronto, Mississauga, ON, Canada
- Prague, Praha, Czech Republic
- Paris, Paris, France
- Darmstadt, Darmstadt, Germany
- Budapest, Budapest, Hungary
- Bengaluru, Bengaluru, India
- Auckland, Auckland, New Zealand
- Warsaw, Warszawa, Poland
- Bucharest, Bucharest, Romania
- Bratislava, Bratislava, Slovakia
- Seoul, Seoul, South Korea
- Madrid, Madrid, Spain
- Taipei, Taipei, Taiwan
- Kyiv, Kyiv, Ukraine
- Wokingham, Wokingham, Berkshire, United Kingdom
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| Certifications | Data not yet provided. | Data not yet provided. |
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| Reviews | Review summary appears after site-level review signal gate opens. | Review summary appears after site-level review signal gate opens. |
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