aster.cephac is a full service provider of Clinical Pharmacology trials and Bioanalytical Services. Since 1975, we have served the pharmaceutical and biotechnology industries with expertise and innovation as an Early Phase clinical trial specialist, and have become the largest independent Bioanalytical unit in Europe.

Whether you require a single study or an entire drug development program, we offer processes, trials and analyses of the highest standard – enabling you to bring your drug to market earlier, accelerate your decision-making process and increase shareholder value.

Phase I-IIa Clinical Pharmacology

Shortening the time to the market

Treating client’s studies as strategic steps in drug development, we strive to provide not only safety assessments, but a variety of additional information to facilitate your "GO - NO GO" decisions.

In a First In Man studies, aster.cephac’s services allow you within one week to do the dose review and take the decision to go to the next dosing level due to its combined services :

• Clinical safety assessments (after the first single dose administration)
• ECG results (after ECG measurement and analysis)
• PK data (after analytical dosing)

  Our experience ranges from regular studies to complex intricated designs, including several studies in one protocol, thus gaining considerable time for you. aster.cephac‘s team provides you with all the relevant and necessary information, including:

• pre-trial consulting
• feasibility evaluation
• study design
• study set-up and project management

Clinical Pharmacology strengths

• Experience and scientific expertise
  - Phase I trial specialist: over 80 clinical trials per year covering a large range of product classes
  - Full time team of physicians and pharmacometry staff
• Full service offering
  - Clinical Pharmacology, Bioanalysis and Pharmacometrics services all under one roof
• Innovative services
  - One of the largest intensive care units for First Administration in Man studies in Europe
  - Extensive cardiovascular expertise and capabilities for QT / QTc prolongation assessments
  - New recruitment call center facilities: large subject panel (15,000)
  - Extensive R&D capabilities: NCE’s, Hormones & Biomarkers
• Proven quality assurance
  - ISO 9001 certified version 2000, GCP and ICH compliant
  - Twice successfully FDA inspected
• First-rate facilities
  - 80 beds, including 40 intensive monitoring beds
  - Fully computerized with telemetry instruments and ECG measurements
  - Many technical rooms dedicated to PD evaluations
  - Rigorous medical supervision
• Customer focus
  - Direct access to key staff for pre-trial consultation and study design
  - Ongoing support from dedicated project team of experts

Exploratory Clinical Pharmacology

Regardless of the study you require, our goal is to provide you with the critical information on safety and drug activity data to enable you to set priorities and make decisions quickly.

We specialize in:

• First In Man studies
• Pivotal Pharmacokinetic studies
• Pharmacodynamic studies
• Thorough Phase I QT/QTc Trials
• POC Studies in patients

Therapeutic Experience

As a phase I trial specialist, aster.cephac has successfully completed more than two thousand safety/tolerability and PK/PD studies on healthy volunteers and on a large number of drug substances designed for use in an extensive range of therapeutic areas such as:

• Cardiovascular
• Thrombosis
• Central Nervous System
• Diabetes
• Bone disease
• Hormone replacement therapy

In 2004, among the 58 clinical pharmacology trials performed :

• 15 New Chemical Entities (NCI) were administered First in Man (FIM)
• 16 Proof-Of-Concept trials
• 13 drug& food interactions studies

Study Subject Recruitment

Because of our central Paris location, a large panel of more than 15,000 volunteers gives aster.cephac access to a large and varied population of healthy volunteers and populations with specific criteria.

A call center composing 20 recruiters accelerate subject recruitment and optimizes the aster.cephac subject database.

Healthy volunteers:

• Healthy males and females
• Elderly males and females
• Post-menopausal females
• Females taking oral contraceptive
• Strict Non-smokers
• Non smokers (less than 10 cigarettes)

Specific populations:

• Allergics
• Asthmatics
• Obeses
• Diabetics (I/II)
• Dyslipidics
• Hypertensives
• Eczema
• Psoriasis
• Penile erectile dysfunction
• HIV

Centrally located in Paris and Poitiers, France, an expanding international client base entrusts its studies to our units. Phase I-IIa trials are conducted at our 9, 200 m² facilities in Paris, which include 80 hospitalization beds, equipped according to the latest technology and international safety requirements. The modern 3, 200 m² bioanalytical unit in Poitiers (1h30 south of Paris) includes 16 LCMS-MS and a rapidly growing Immunoassay department. aster is certified ISO 9001, twice successfully FDA inspected and cephac is GLP grade A.

Pharmacometrics

Specialist collaboration from project inception to completion

As part of its Clinical Pharmacology and Bioanalytical Services, aster.cephac offers pharmacometric support through a multidisciplinary approach to clinical data analysis. We provide comprehensive pharmacometric services from clinical protocol development to final Integrated Clinical Study Reports. You will work alongside a team of clinical scientists specializing in the fields of Data Management, Pharmacodynamics, Pharmacokinetics, Biostatistics and Medical Writing. Furthermore, we assign you a pharmacometry study coordinator to liaise with personnel across all service activities, providing information and ensuring that communication remains clear and efficient at all times.

Pharmacometrics strengths

• Experience and scientific expertise
  - A multi-disciplinary team of experts provides the highest quality clinical support and rapid turnaround timelines
• Full service offering
  - Clinical Pharmacology, Bioanalysis and Pharmacometrics services all under one roof
• Innovative services
  - The Oracle Clinical® data management system leverages analysis capabilities
• Proven quality assurance
  - In accordance with 21 CFR part 11, FDA & ICH6 guidelines
• First-rate facilities and equipment
  - Latest versions of hardware and software, secured access, firewall…
• Customer focus
  - A pharmacometry study coordinator liaises information and personnel across activities
  - Direct access and ongoing consultation with key project staff

Bioanalysis

Bioanalytical services

Timely and accurate data regarding the safety and efficacy of your drug product is critical for success at every stage of drug discovery and development. The aster.cephac Bioanalysis division applies its experience, capabilities and the latest technology to deliver outstanding bioanalytical support for your project.

We specialize in:

• Bioanalytical assay method development
• low-level analysis of drugs and metabolites in complex biological matrices
• biomarker analysis
• Immunogenicity testing

Our objective is to guide our clients through the selection process of lead candidates and support pre-clinical and clinical studies for regulatory submissions of investigative and new drug substances. These include:

Pre-clinical development	Veterinary drugs
Early drug development	Marketed drugs
Late phase clinical trials

Bioanalytical strengths

• Experience and scientific expertise
  - More than 250 bioanalytical projects run per year
  - Leader in the fields of mass spectrometry and immunoanalysis
  - Large method library
  
• Full service offering
  - Clinical Pharmacology, Bioanalysis and Pharmacometrics services all under one roof
  
• Innovative services
  - Extensive R&D capabilities for NCE’s, Hormones & Biomarkers
  
• Proven quality assurance
  - Accredited and Good Laboratory Practice certification since 1990
  - Implementation of FDA 21 CFR part 11
  - Adherence to FDA and OECD guidelines for development and validation processes
  
• First-rate facilities - Automated processing and analysis of biological samples
  - Large technical platform: LC-MS/MS, GC-MS, HPLC, Immunoanalysis
  - Rapid turnaround bioanalysis for ascending dose studies, Phase I studies
  - High volume analytical capabilities for Phase II & III trials
  
• Customer focus - Direct access to key staff, through dedicated Client Contacts
  - Continuous consultations with a dedicated project team of experts
  - Reporting database to ensure on-time reporting

Method development

Based on our 18 years’ accumulated expertise and knowledge, we offer more than 400 validated proprietary methods that are ready for use with very little lead-time. Validation criteria follow guidelines from aster.cephac SOPs, which are based on recommendations by the FDA and OECD.

Drugs and metabolites analysis

Bioanalytical support from Pre-clinical to Post-marketing studies In order to support the bioanalysis of various classes of compounds, aster.cephac offers a large range of techniques and methods such as:

• Mass spectrometry: 16 LC-MS/MS, 6 GC-MS
• Classical HPLC: 10 HPLC systems equipped with UV, fluorescence and electrochemical detectors
• Immunoanalysis: EIA/RIA, ELISA measurements for routine analysis of a variety of molecules including steroids, hormones, proteins, peptides and carbohydrates

Biomarkers analysis

Biomarker development for various therapeutic areas include:

cardiovascular	gynecology
CNS	HRT
diabetes	Bone disease
nephropathy	Liver disease
inflammation
thyroid disease

Immunogenicity testing

Our extensive Quality Assurance team, comprising 14 full-time members of staff, diligently seeks the highest levels of accuracy, safety and efficiency. Members of staff are routinely trained in the latest best practices and safety methods, and our equipment is meticulously controlled and maintained.

As a result, aster.cephac is :

• GCP-ICH compliant and our processes are all registered in Standard Operating Procedures
• our clinical operations have been ISO 9001 certified (version 2000), and have recently been twice successfully inspected by the FDA
• our bioanalytical unit is GLP compliant and has been awarded Grade A status since 1994.
• Watson's® Laboratory Information Management System
• 21 CFR Part 11 compliant (Oral Clinical®, sample tracking randomization)

Our greatest asset is our staff – all 400 of them. Our specialists work on a one-to-one basis with you throughout the project to ensure that your needs and expectations are fully met. aster.cephac has created a stimulating environment for staff to develop their careers and grow with us. As a result, key staff turnover is extremely low. For instance, the full time investigators, Study Directors and project managers you will be working with have been with aster.cephac for an average of 10 years.

We take pride in our staff's loyalty, which, in turn, facilitates long-term and stable relationships with sponsors.

Our strength originate from our corporate values

1. Scientific expertise gained from 30 years’ experience
2. Full service offering – Clinical Pharmacology – Bioanalysis – Pharmacometrics
3. Innovative services
4. Proven quality assurance
5. First-rate Clinical & Bioanalytical facilities
6. Customer focus

For more information, please contact:

Mr Frans Verhaaren
Business Dvt Director
SGS Life Science Services
3-5 rue Eugene Millon
Paris 75015 France
Phone: + 33 1 53 78 16 31
Fax: + 33 1 45 54 28 64
E-mail:

If you are interested in contacting this center to discuss placing a clinical trial there, please complete and send the E-mail form below. A representative from the research center will then follow up with you.

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Last updated on February 19, 2008

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