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As a client, you want someone who:
- understands the culture and particular unique needs of an
emerging company.
- has a successful product development track record.
- is selective about the projects they take on, assuring high quality work
- is focused, hands-on, cost-effective, and provides reliable service - the first time.
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Arkios has never had a project discontinued due to performance.
Customer satisfaction is our number one concern.
If we do not believe your project is a good fit for us, we will tell you.
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Early Stage Development
- Strategic Regulatory Plans
- Preclinical Vendor Management
- Preclinical / Pre-IND programs
- FDA Conferencing
- IND Development and Submission
- Management of Phase I trials
Clinical Trial Management
- Clinical Trial Design & Management
- Protocol Development
- Investigator Recruitment
- Monitoring / Quality Assurance
- Regulatory Affairs
- Data Management
- Biostatistics
- Medical Writing
- NDA Writing and Filing
Items from this list are available individually on an as-needed basis. |
Therapeutic Areas of Experience:
- AIDS-related products
- Anti-inflammatories
- Antibiotics/anti-infectives
- Anticancer agents including vaccines
- Antifungals
- Antihistamines (H1, H2, H3)
- Antiulcer and other GI products
- Antiviral agents
- Biologics including vaccines and plasma products (standard and hyperimmune globulins)
- Cardiovascular including thrombolytics, anti-hypertensives, and others
- CNS
- Dermatology
- Hormones
- Ob-Gyn products
- Ophthalmic products
- Pharmacokinetic (Phase I) Testing
- Topical antibiotics and other topical products
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Lead Consultant and Founder - Dr. Gary Pekoe, PhD
Dr. Pekoe has over 25 years experience in successful product development. He managed the clinical development of the only single-agent topical antibiotic approved by the FDA, Bactroban (mupirocin) for Beecham (GSK). As Director of Clinical Operations, he helped build the clinical department at Univax Biologics, directed a number of vaccine and source plasma programs, and authored their only approved BLA (WinRho SD). Dr. Pekoe has been an investigator on over 200 studies and developed the widely imitated SMO model. Dr. Pekoe has a thorough understanding of the product development process.
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