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Phase I-IIA Clinical Pharmacology



AAIPharma offers almost 30 years of clinical pharmacology expertise to guide and support your development plans when entering into first in man or first in patients. Our clinical pharmacologists, experienced medical research teams and network of specialist physicians provide regulatory compliant solutions to exploratory development and clinical pharmacology needs.

 

 

Our areas of expertise include:

  • Phase I-IIa Clinical Pharmacology
    • Single Ascending Dose
    • Multiple Ascending Dose
    • SAD/MAD adaptive designs
    • Safety and tolerability
    • First in Human (FIH)
    • Drug-drug interaction (with bioanalytical support)
    • Drug-food interaction
    • Proof of concept studies in special populations
    • Thorough QTc/intensive monitoring
    • Long-term confinement studies
    • Out-patient studies
  • Generic Bioavailability/Bioequivalence
    • USA, Canadian, and European regulatory expertise
    • On-time recruitment employing a 12,000 subject database of normal, healthy volunteers
    • Bioanalytical services including assay development

 

AAIPharma performs Phase I/IIa trials in our dedicated units in Neu-Ulm, Germany and also in Morrisville, North Carolina, USA. Regulatory professionals can review or prepare your pre-study information, including the IMPD, IND or CTA submission packages to ensure submissions are in line with European, FDA, and Canadian guidelines.

 

CLINIC SPECIFICATIONS Morrisville, NC, USA Neu-Ulm, Germany
Beds/Subject Database
 210;
12,000 subject database		 80; 8,000 subject database
Ambulatory Bed Capacity
 180 68, beds for special
population configurations
First in Human, Intensive Ward
 12-20 beds;
nearby hospital 		12 beds; nearby hospital;
anesthesiologist on-site
Telemetry Yes Yes
DEA - Compliant
 Yes Yes
Qualified Person on-site Not Applicable Yes

 

Through AAIPharma's integrated GMP manufacturing and packaging facility and on-site Qualified Persons (QP), drug supplies for use in your trials can be manufactured or imported, qualified and released without delay. We offer significant capabilities in Clinical Services, Data Management, Statistics, Formulation Development, Pharmaceutical Analysis, Clinical Trial Manufacturing, Packaging & Distribution, Bioanalysis and pharmacokinetic analysis under one roof thus allowing for optimization of project costs and timelines.