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Clinical Conduct

Analab Clinical Research team members have experience working with large, entry stage and virtual biopharmaceutical companies. We have the proven expertise and flexibility to assist in the areas needed with tailored services that help our clients achieve their objectives. Selected areas of our clinical conduct are reviewed below.

Clinical Procedures:  Some of the treatment and assessment procedures with which we have experience include: EKG, EKG telemetry, lumbar puncture, evoked potentials, pain assessment models, cognitive testing, skin biopsy, skin swab, skin patch adhesion testing and pulmonary function testing.

Routes of Administration: In addition to oral administration we have experience with intravenous, sub-cutaneous, intra-muscular, sub-lingual, buccal, suppository, transdermal and topical, intraocular and inhalant routes of administration.

Test Article Types: Analab Clinical Research staff has experience with the most frequent test articles types and also understand the clinical issues associated with testing immunomodulators, infective disease agents including HCV/HIV, gene therapy, opioids and other analgesics, cardiac antiarrhythmics, and vaccines.

Training & QA: A training program built upon current, detailed and well-documented training with comprehensive assessments assures that our staff follows pertinent protocol and client-specific procedures during study conduct. Our Quality Assurance policies provide guidance for issue resolution and SOP management.

Data entry: We utilize multiple electronic data capture and clinical trial management systems, as well as paper, based on client preferences.

Protocol Execution: Our staff have experience executing procedure intensive, complex protocols. Our planning, training and strong teamwork results in precision execution and high quality data.

Support Services

Laboratory Services:  Our local reference laboratory is only 6 minutes away, has over 15 years of experience in Phase I/II/III clinical research and delivers CDISC-SDTM compliant SAS® datasets. Standard safety lab specimens are usually transported by their on-call courier service to their reference lab within 1/2-2 hours of collection and reported to Analab Clinical Research within 4 hours of collection. Stat courier and testing service are also available 24/7.

Special Specimen Processing: Analab Clinical Research provides routine and protocol-specific specimen processing for pharmacokinetic, pharmacodynamic and safety testing. Our team members have worked with many bioanalytical and biomarker specialty testing laboratories, including esoteric immunology and allergy testing specialty laboratories. We have experience processing serum, plasma, cerebrospinal fluid, cerebrospinal fluid-white blood cell and peripheral blood mononuclear cell specimens.

Pharmacy Services:  A registered pharmacist with experience in compounding pharmacy and over 25 years of total experience in Phase I/II/III pharmacy research manages our pharmacy which performs a wide range of preparation and dispensing procedures. Our pharmacy team also assists in writing and reviewing pharmacy manuals for protocol-specific test article preparation.

Study Protocol Services:  Analab Clinical Research offers study protocol support services and will co-develop protocols, write and review case report forms, perform strategic and execution based analysis of protocols, and review protocols for completeness, safety and execution feasibility.

Regulatory Activities: An independent review board (IRB) meets three times per week providing rapid review of submitted documents with approval time from initial submission as short as 2 days, and approved document availability often within 24 hours of the review meeting.  We can assist with or completely manage all aspects of IRB submissions.

Adaptive design:  Adaptive protocol designs allow rapid adjustment to protocol parameters on-study and leverage the study investment.  Analab Clinical Research team members understand the forethought and planning required to execute these studies properly.