The Experts in Clinical Pharmacology, Nonclinical, and Translational Medicine

SERVICES

Services Overview Document

for 2015-2016

 

To find more publications from DUCK FLATS, visit our document repository HERE

OUR SERVICES SPAN ACROSS MULTIPLE THERAPEUTIC AND SCIENTIFIC FIELDS

• Alzheimer’s Disease

• Anesthesia and Critical Care

• Biotechnology Compounds

• Cardiovascular

• Combination Drug Therapy

• Device/Drug Combinations

• Endocrinology

• Gastrointestinal

• HIV

• Allergy/Immunology

 

• Infectious Disease

• Neurology/Psychiatry

• Oncology

• Metabolic Diseases

• Women’s Health

• Injectable Products

• Transplantation

• Pulmonary/Transdermal/Intranasal

   ICV Drug Delivery

STRATEGIC DRUG DEVELOPMENT

Our group of experts can help you establish and implement a development plan, focusing on the mechanism of action, pharmacokinetics and pharmacodynamics of the drug or biotechnology compound being developed.  The key focus is to determine the ideal translational medicine program that will ultimately support the approved indication in the targeted patient population.

NONCLINICAL CONSULTING AND STUDY MANAGEMENT

We can help you set your strategy for targeted drug development plans specific to therapeutic indication, drug development implementation, and provide guidance for the right group of experiments for both in-vitro and in-vivo non-clinical programs -pharmacology, toxicology, and non-clinical PK/metabolism /ADME.  Our experts can assist with your determination of optimum bioanalytical development, and assist with your regulatory submissions (both domestic and international).

CLINICAL CONSULTING

With our expertise, we can help you design and manage:

  • First-time-in-man studies
  • Safety
  • PK/PD
  • TQT/cardiac safety
  • PK/Efficacy
  • Phase 1 clinical programs
  • Absolute bioavailability
  • Relative bioavailability
  • Food interaction
  • Special populations
  • Gender studies
  • Renal impairment or hepatic impairment
  • Elderly or pediatric   -Drug/drug interaction studies
  • Radiolabeled metabolism trials
  • Proof-of-Concept trials
  • Biopharmaceutics program linked to CMC development (bioequivalence, bioavailability studies)
  • Phase II dose-ranging programs
  • In-licensing & Out-licensing strategies
  • Due-diligence review
  • Regulatory submission strategies (domestic and international)
PHASE 1/2 CLINICAL TRIALS

DUCK FLATS handles clinical trials from start to finish.  Our experienced staff and consultants will tailor a customized management plan according to your individual study needs.

 

Clinical Trial Management for Clinical Pharmacology and Phase 1/2 trials including:

  • Phase 1 Oncology
  • First-time-in-man studies
  • Patient and Healthy Volunteer Studies
  • Complex PK/PD Studies
  • Proof-of-concept trials
  • Pediatric and elderly trials
  • Cardiac safety (TQT) trials
  • Impaired populations (renal, hepatic)
  • Drug-Drug Interaction Studies (DDI)
  • Bioavailability Studies
PK ANALYSES AND STATISTICS

DUCK FLATS provides our clients with a variety of analyses to fit their needs.  Our Nonclinical and Clinical PK Scientists, Statisticians, and POP PK Scientists can help design the right analyses to achieve your program goals.

 

Our list of Analyses include:

 

  • Modeling and Simulation
  • PK/PD
  • TK
  • POP PK and POP PK/PD
  • Clinical Trial Simulations
  • IV/IVC
  • First-in-man calculations
  • Bridging nonclinical to clinical and biomarkers to clinical efficacy
  • Integrated PK and PK/PD meta analyses for NDAs

 

All analyses meet GLP/GCP standards

MEDICAL WRITING

The DUCK FLATS medical writing team consists of highly experienced writers with extensive backgrounds in a variety of therapeutic areas.

 

Our writers work closely with the scientific and medical subject matter

expert(s) to ensure consistency and thorough development in all writing deliverables.

 

DUCK FLATS  has in-office scientific and medical subject matter experts for direct access by our medical writers.

KEY WRITING ACTIVITIES INCLUDE:

 

  • INDs
  • NDAs
  • FDA Briefing Documents
  • Clinical Study Reports (CSR)
  • Non-Clinical Reports
  • Validation Reports
 Investigator Brochures (IB) Orphan Drug Applications Protocols/ Amendments Patient Safety Narratives FDA White Papers Safety Updates

Contact Information

Phone:  315-689-3407

Email:  CLICK HERE

© 2016 DUCK FLATS, LLC. All Rights Reserved.

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