Ssb0lndwqrtakn5pulxq profil

Profil Institute for Clinical Research, Inc.

Chula Vista, CA, US

Profil Institute for Clinical Research, Inc. is the leading clinical research organization (CRO) exclusively focused on diabetes, obesity and NAFLD/NASH. We are recognized globally for our scientific expertise, scope of research methodologies and experience with every clinically relevant drug class and device category in diabetes.

We provide comprehensive CRO services from consulting for strategic clinical development and regulatory management through design and completion of complex clinical trials, including the reporting and publication of final study results.

Profil Institute has built a reputation as the leading provider of early phase clinical research and development of metabolic drugs and devices. We have completed more than 280 early phase metabolism projects, which is more than any other early engagement CRO in the U.S. Additionally, we have conducted studies within every clinically relevant drug class... Show more »

Profil Institute for Clinical Research, Inc. is the leading clinical research organization (CRO) exclusively focused on diabetes, obesity and NAFLD/NASH. We are recognized globally for our scientific expertise, scope of research methodologies and experience with every clinically relevant drug class and device category in diabetes.

We provide comprehensive CRO services from consulting for strategic clinical development and regulatory management through design and completion of complex clinical trials, including the reporting and publication of final study results.

Profil Institute has built a reputation as the leading provider of early phase clinical research and development of metabolic drugs and devices. We have completed more than 280 early phase metabolism projects, which is more than any other early engagement CRO in the U.S. Additionally, we have conducted studies within every clinically relevant drug class in diabetes over the last decade. With the knowledge and experience we have accumulated in the field of metabolism research, we are proud to be a trusted adviser and service provider for companies from virtual to large pharma throughout the Americas, Europe and Asia.

Profil Institute’s key scientists are recognized internationally for their contributions in the field of metabolism research. They serve on the editorial boards of major scientific journals, have published more than 500 articles in peer-reviewed journals, and regularly present at leading scientific conferences. Our scientific expertise, in combination with our experience and portfolio of methodologies, puts us at the forefront of diabetes, obesity and NAFLD/NASH clinical research and development. Within the industry, we are renowned for setting and delivering on a higher level of expectations for conclusive data and comprehensive clinical planning.

Recent publications:

  • Fry AR, Krentz AJ, Hompesch M. Considerations in biosimilar insulin device development Biosimilars. 2016 February 16. Volume 2016:6 Pages 9—15
  • Hompesch M, Krentz AJ. Biosimilar insulins: current and future perspectives Diabetes Manag. 2015 5(6), 405-409. doi: 10.2217/dmt.15.33.
  • de la Peña A, Yeo KP, Linnebjerg H, Catton E, Reddy S, Brown-Augsburger P, Morrow L, Ignaut DA. Subcutaneous Injection Depth Does Not Affect the Pharmacokinetics or Glucodynamics of Insulin Lispro in Normal Weight or Healthy Obese Subjects. J Diabetes Sci Technol. 2015 Jul;9(4):824-30. doi: 10.1177/1932296815573865. Epub 2015 Feb 19.
  • Heinemann L, Home PD, Hompesch M. Biosimilar insulins: guidance for data interpretation by clinicians and users.
    Diabetes, Obesity and Metabolism. 2015 May 13. doi: 10.1111/dom.12491. [Epub ahead of print]
  • Krentz AJ, Fujioka K, Hompesch M. Anti-Obesity Pharmacotherapy: The Intercontinental Regulatory Divide. Drugs. 2015 May 12. doi: 10.1007/s40265-015-0404-z.
  • Heise T, Korsatko S, Nosek L, Coester HV, Deller S, Roepstorff C, Segel S, Kapur R, Haahr H, Hompesch M. Steady state is reached within two to three days of once-daily administration of degludec, a basal insulin with an ultra-long duration of action. J Diabetes. 2015 Jan 12. doi: 10.1111/1753-0407.12266.
  • Hompesch M, Jones-Leone A, Carr MC, Matthews J, Zhi H, Young M, Morrow L, Reinhardt RR. Albiglutide does not impair the counter-regulatory hormone response to hypoglycaemia: a randomized, double-blind, placebo-controlled, stepped glucose clamp study in subjects with type 2 diabetes mellitus. Diabetes Obes Metab. 2015 Jan; 17(1):82-90. doi: 10.1111/dom.12398. Epub 2014 Oct 26.
« Show less

Profil Institute for Clinical Research, Inc. has not listed any services.

Medical Device Clinical Trials
Price on request
Request a quote for more information about this service.
Patient Recruitment
Price on request

Profil Institute’s study participant recruitment services

Profil Institute is relied upon to rapidly recruit for clinical studies with narrow and complex inclusion criteria. We have a highly skilled Recruitment Team specialized in providing feasibility analyses of study protocols and fulfilling study participant recruitment... Show more »

Profil Institute’s study participant recruitment services

Profil Institute is relied upon to rapidly recruit for clinical studies with narrow and complex inclusion criteria. We have a highly skilled Recruitment Team specialized in providing feasibility analyses of study protocols and fulfilling study participant recruitment needs for metabolic studies. This team of experts has supported the recruitment needs for the 245 clinical research trials that Profil Institute has completed in the therapeutic areas of type 1 and type 2 diabetes, obesity and NAFLD/NASH.

We have assembled a database of nearly 30,000 pre-screened study participant candidates of which nearly two-thirds are part of the patient population. The database is segmented by T1D, T2D, obese, lean and healthy, and further segmented by detailed information about other medical conditions, specific medications, age, gender and ethnicity. With this extensive database, we are able to recruit study participants quickly and efficiently, and are recognized as a leading provider of first-in-patient clinical trials for diabetes and obesity.

Facts and figures about Profil Institute’s recruitment services:

  • Study participant drop-out rate of 0%-5% compared to an industry average of 15%-20%*
  • Experience in difficult to recruit patient populations:
    • Narrow or complex inclusion criteria
    • Concomitant disease inclusion or exclusion
    • Specific medication inclusion or exclusion
    • Narrow age and ethnicity requirements
    • Extended in-house stays of up to 8 weeks
  • Database of nearly 30,000 pre-screened study participant candidates
    • Pre-screened through a detailed medical history review
    • Segmented by T1D, T2D, obese, lean, healthy, medical conditions, medications, age, gender and ethnicity
  • Study fill-rate of 100% with protocol-specific feasibility analysis
  • More than quarter of studies filled before projected timelines
« Show less
Clinical Quality Monitoring
Price on request

Ensuring safety of study participants and integrity of clinical results

At Profil Institute there is no room for compromise when it comes to the safety of our study participants and the validity and integrity of our research data. Because best-in-class quality is a top priority for us, we have stringent monitoring, quality... Show more »

Ensuring safety of study participants and integrity of clinical results

At Profil Institute there is no room for compromise when it comes to the safety of our study participants and the validity and integrity of our research data. Because best-in-class quality is a top priority for us, we have stringent monitoring, quality and compliance policies observed throughout every step of our clinical research, whether at our San Diego facility or at another certified site.

Features of Profil Institute’s quality management program include:

  • Compliance with E6 ICH GCP Guidelines; FDA Code of Regulations CFR title 21: parts 11, 50, 54, 56, 312, 812, and PhRMA principles on Conduct of Clinical Trials
  • Internal audit program to ensure continual GCP compliance
  • Oversight of sponsor and FDA visits and audits
  • Third party vendor audit program with a routine follow up audits
  • All staff training for GCP training, CAPA investigations, and electronic Document Management Systems
  • Dedicated team of quality assurance and quality control associates with specialized therapeutic training
« Show less
Clinical Trial Monitoring
Price on request

Ensuring safety of study participants and integrity of clinical results

At Profil Institute there is no room for compromise when it comes to the safety of our study participants and the validity and integrity of our research data. Because best-in-class quality is a top priority for us, we have stringent monitoring, quality... Show more »

Ensuring safety of study participants and integrity of clinical results

At Profil Institute there is no room for compromise when it comes to the safety of our study participants and the validity and integrity of our research data. Because best-in-class quality is a top priority for us, we have stringent monitoring, quality and compliance policies observed throughout every step of our clinical research, whether at our San Diego facility or at another certified site.

Features of Profil Institute’s clinical monitoring program include:

  • Full scope monitoring services
  • Rigorous study-specific CRA preparation
  • Continuous Risk Contingency Assessments (RCA)
  • Regional CRAs to reduce over-all costs
  • Dedicated team of CRA specialists extensively trained in metabolic study procedures and regulatory requirements
« Show less
Clinical Data Analysis
Price on request

Translating trial outcomes into immediate, relevant and usable analytics

Profil Institute’s in-house data management leadership has more than 20 years of experience in analyzing data from metabolic-focused clinical studies. Our team works directly with clinical project managers and clients to deliver integrated data... Show more »

Translating trial outcomes into immediate, relevant and usable analytics

Profil Institute’s in-house data management leadership has more than 20 years of experience in analyzing data from metabolic-focused clinical studies. Our team works directly with clinical project managers and clients to deliver integrated data management and statistical services, as well as to contribute their expertise to final clinical study reports.
Profil Institute’s clinical data management and statistical services include:

  • Robust EDC and CRF/eCRF database
  • Compliant with CFR 21 Part II, CDISC, ICH GCP and good CDM practices
  • Reconciliation of data from external sources for CRF data consistency
  • Clinical Data Management System with real-time access for sponsors and study teams
  • Ad hoc trending and data snapshots for dose escalation decisions, study design review, and study progress
  • Development of Statistical Analysis Plan (SAP) and corresponding tables, listings, and figures
  • Pharmacokinetic (PK) and Pharmacodynamic (PD) parameter analysis and PK/PD modeling
  • Meta-analysis for regulatory filings
  • Data management and biostatistical specialists with specific metabolic expertise
« Show less
Data Management
Price on request

Translating trial outcomes into immediate, relevant and usable analytics

Profil Institute’s in-house data management leadership has more than 20 years of experience in analyzing data from metabolic-focused clinical studies. Our team works directly with clinical project managers and clients to deliver integrated data... Show more »

Translating trial outcomes into immediate, relevant and usable analytics

Profil Institute’s in-house data management leadership has more than 20 years of experience in analyzing data from metabolic-focused clinical studies. Our team works directly with clinical project managers and clients to deliver integrated data management and statistical services, as well as to contribute their expertise to final clinical study reports.
Profil Institute’s clinical data management and statistical services include:

  • Robust EDC and CRF/eCRF database
  • Compliant with CFR 21 Part II, CDISC, ICH GCP and good CDM practices
  • Reconciliation of data from external sources for CRF data consistency
  • Clinical Data Management System with real-time access for sponsors and study teams
  • Ad hoc trending and data snapshots for dose escalation decisions, study design review, and study progress
  • Development of Statistical Analysis Plan (SAP) and corresponding tables, listings, and figures
  • Pharmacokinetic (PK) and Pharmacodynamic (PD) parameter analysis and PK/PD modeling
  • Meta-analysis for regulatory filings
  • Data management and biostatistical specialists with specific metabolic expertise
« Show less
Scientific Advisory Board Management
Price on request
  • Scientific consulting and participation on scientific advisory boards
  • Establishing and managing scientific advisory boards for our clients
  • Scientific consulting and participation on scientific advisory boards
  • Establishing and managing scientific advisory boards for our clients
« Show less
Technical writing
Price on request
  • Investigator brochures
  • Target product profiles and prophetic package inserts
  • Regulatory documents, including Investigational New Drug (IND) filings and annual IND reports
  • Data and Safety Monitoring Board (DSMB) reports
  • Investigator brochures
  • Target product profiles and prophetic package inserts
  • Regulatory documents, including Investigational New Drug (IND) filings and annual IND reports
  • Data and Safety Monitoring Board (DSMB) reports
« Show less
Scientific Publication
Price on request
  • Scientific publications for peer-review journals
  • Oral and poster presentations for national and international industry and scientific conferences
  • Scientific publications for peer-review journals
  • Oral and poster presentations for national and international industry and scientific conferences
« Show less
Clinical Trial Management
Price on request

Clinical research of metabolic drugs and devices

Profil Institute provides clinical research of drug and device candidates for diabetes, obesity, NAFLD/NASH and related metabolic disorders. We are internationally recognized for our scientific expertise and as an innovator of methodologies to improve metabolic studies.

We... Show more »

Clinical research of metabolic drugs and devices

Profil Institute provides clinical research of drug and device candidates for diabetes, obesity, NAFLD/NASH and related metabolic disorders. We are internationally recognized for our scientific expertise and as an innovator of methodologies to improve metabolic studies.

We have conducted more than 280 early phase diabetes, obesity and NAFLD/NASH clinical research and development projects, involving every clinically relevant diabetes drug class and device category. We have vast experience in small and large molecule therapies, biologics and biosimilars. Our expertise encompasses all routes of administration for diabetes medications, including oral, subcutaneous injection, infusion, transdermal and inhaled, as well as medical devices, including glucose monitoring systems, advanced biosensors and drug delivery devices. We have experience and expertise in conducting studies for NAFLD and NASH, and are able to apply today’s most advanced imaging and circulating biomarker methodologies to your NAFLD and NASH research.

Our clinical operations team is comprised of leading experts in the design and execution of metabolic clinical trials, including proof of mechanism and first-in-human. We conduct clinical research studies at our state-of-the-art clinical research facility in San Diego, as well as providing site selection and management services for multi-center studies.

« Show less
Regulatory Affairs Consulting
Price on request

Regulatory services that encompass the needs of our international clients

Profil Institute strategically prepares for and navigates regulatory requirements throughout your product development life cycle. Our in-house regulatory leadership has over 25 years of experience in both the U.S. and European regulatory... Show more »

Regulatory services that encompass the needs of our international clients

Profil Institute strategically prepares for and navigates regulatory requirements throughout your product development life cycle. Our in-house regulatory leadership has over 25 years of experience in both the U.S. and European regulatory environments.

We work with our global clients to analyze IND/CTA and NDA/ANDA regulatory options, build clinical development programs, and research marketing opportunities afforded by each regulatory path. Our services include assessment of a compound’s regulatory readiness, preparation of all documents for global regulatory authorities, and management of all regulatory steps from submission and maintenance through final clinical study reports.

Profil Institute’s regulatory services include:

  • Design and management of strategic regulatory plan in compliance with institutional review boards, FDA, EMA, BfArM and other global regulatory authorities
  • Gap analysis for FDA and EMA regulatory readiness by our team of experts
  • Preparation of protocols and documentation by experienced medical writers
  • Submission of regulatory documentation in electronic or paper formats
  • Project management from submission through clinical study reports
  • Representation of our clients with regulatory authorities
  • Management of regulatory affairs for virtual to large Pharma, including companies commencing novel drug development
« Show less
Clinical Development Strategy
Price on request

Strategic early engagement clinical development for metabolic drugs and devices

Our clients rely upon us to deliver a clinical development package with conclusive data and all necessary regulatory and safety documentation to support the effective treatment of diabetes, obesity, NAFLD/NASH and related metabolic... Show more »

Strategic early engagement clinical development for metabolic drugs and devices

Our clients rely upon us to deliver a clinical development package with conclusive data and all necessary regulatory and safety documentation to support the effective treatment of diabetes, obesity, NAFLD/NASH and related metabolic disorders.

We design and implement clinical development strategies that allow our clients to make go/no-go decisions as early as possible and ensure a solid scientific foundation for compounds entering later stages of clinical development.

Our clinical development services include:

Clinical strategy

  • Preclinical GAP analysis and back integration plan
  • Compound and stage-specific scientific advisory board management
  • Identification and tracking of key performance indicators
  • Global regulatory services and oversight
  • Dedicated key account management, medical science liaison, and administrative support

Project management

  • Site qualification and selection
  • Rapid launch for single and multi-site protocols
  • Real-time reporting via CTMS
  • Full scope monitoring services

Asset management services

  • Market research
  • New product strategy
  • Business partnership and licensing support
« Show less
Human
Obesity & Diabetes
Diabetes Type 2
Project Management & Consulting Services
Price on request
Request a quote for more information about this service.
Data Analysis and Management
Price on request
Request a quote for more information about this service.
Clinical Research
Price on request
Request a quote for more information about this service.
Scientific Communication
Price on request
Request a quote for more information about this service.
Editorial Support
Price on request
Request a quote for more information about this service.
Clinical Trials, Consulting, and Management
Price on request
Request a quote for more information about this service.
Clinical Data Collection, Analysis and Management
Price on request
Request a quote for more information about this service.
Regulatory Affairs Services
Price on request
Request a quote for more information about this service.
Computational & Statistical Analysis
Price on request
Request a quote for more information about this service.
Research Management
Price on request
Request a quote for more information about this service.
Ask A Question Find what you're looking for? If not, you can ask this lab a question:

Profil Institute for Clinical Research, Inc. has not received any ratings.

Be the first to endorse Profil Institute for Clinical Research, Inc.

Endorse this lab