Clinical and Ancillary Services
Clinical Services
Clinical Services are provided at our state of the art clinical research institute located in Chula Vista, CA (just south of downtown San Diego).
The key characteristics of our staff and facilities include:
- 34 clinical beds
- Full scope, USP (United States Pharmacopoeia) compliant pharmaceutical services
- > 175 employees (>128 FTE) trained and experienced in all aspects of professional, high quality early phase clinical research processes
- Location in highly populated (> 3 million), ethnically diverse,
greater San Diego area
Profil’s research services are focused on early phase clinical studies in the areas of Diabetes and Obesity.
Within these indications our clinical studies can include complex methodological approaches, like:
- Automated glucose clamp studies
- Proof-of-concept studies: endogenous glucose turnover, metabolic pathways, stable tracers, tissue biopsies
Profil also has extensive experience in:
- First-in-man, single and multiple ascending dose studies
- Bioequivalence studies, drug-drug interaction studies
- In-house extended stay studies, complex methods studies
Pharmaceutical Services
Study drug and device management are provided
by Profil’s Pharmaceutical Services department.
The scope of pharmaceutical services includes:
- Compliance with USP standards for immediate use compound preparations
- Reconstitution and dilution of sterile formulations under aseptic conditions for injection
- Filling, packaging, labeling, accounting of dosage forms from bulk material
- Preparation of blinded study medication
- Storage of study medication under various temperature controlled conditions
- Shipping and receiving of study medication nationally and internationally
- Consulting for study design and drug management in clinical research setting
- Long-term retention for bioequivalence samples
- Management of investigational drug destruction
Ancillary Services
Regulatory Affairs
Profil can support regulatory filing requirements for the initiation of clinical trials in the USA, through a network of regulatory specialists who are able to support IND and IDE filings.
Central IRB
As an independent clinical research institute, Profil works with numerous certified independent Institutional Review Boards (IRBs), also called ethical committees. Since Profil operates in a multi-ethnic environment, we can also manage the translation of informed consent forms into various languages.
Data Management
We are able to utilize sponsor selected eCRF solutions or hybrid data capturing systems based on scanable paper CRFs, thus enabling us to meet extremely short timelines while achieving minimal data entry errors. Data Management services typically include the use of coding dictionaries such as MedDRA or the WHO Drug Dictionary, enhanced, fully audit-trailed SQL-databases, and the ability to adapt easily to data export specifications.
Statistics
In collaboration with partners, Profil offers the full range of biostatistical services: sample size calculation, statistical analysis planning, randomization, statistical data analysis, provision of tables, listings, graphs and statistical reports both for reporting and publication.
Medical Writing
More than 100 original articles and reviews, primarily published in highly ranked international journals highlight Profil's scientific expertise.
Profil works with skilled medical writers who closely cooperate with our scientists, investigators and other experts to develop study protocols and complete study reports.