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Welcome to
Impetus Clinical Research

One-stop solution for your quality clinical research

silder2

Welcome to
Impetus Clinical Research

One-stop solution for your quality clinical research

Your one-stop solution for clinical research & development

We are an alliance of international clinical research professionals dedicated to provide quality and cost efficient services. We offer the full range of activities for your individual clinical trials and global drug development programs.

One-stop solution

We provide a full range of activities for individual clinical trials and global drug development programs.

Experience

Benefit from the extensive knowledge of our senior clinical trial professionals.

Cost effective

Our streamlined, efficient structure helps you to maximize your return on investment.

Make the smart choice – choose to partner with Impetus Clinical Research and benefit from the following:

Experience

Gain access to a team of senior clinical trial professionals from different countries who will bring their extensive knowledge to your project

‘Can do’ attitude

Benefit from highly motivated team members who will display an excellent sense of ownership and commitment when it comes to delivering your clinical trial

International presence

Offices in many of the main European countries for clinical research

Cost-effectiveness

No ‘excess baggage’ or expensive overheads, allowing you to achieve cost savings

Flexibility

Use us for one aspect of your trial needs or for a more comprehensive service

Agility

Responsive to changing environment

AREAS OF EXPERTISE

Impetus Clinical Research is a full service, international operating provider for early and late stage clinical research programs.

 

We conduct clinical research in the following therapeutic areas:

  • Advanced therapy medicinal products
  • Cardiovascular
  • Central Nervous System
  • Dermatology
  • Diabetes
  • Gastroenterology
  • Haematology
  • Immunology and Rheumatology
  • Infectious diseases
  • Metabolic diseases
  • Medical devices
  • Oncology
  • Psychiatry
  • Rare and ultra-rare (orphan) diseases
  • Urology and Nephrology
  • Vaccines

Development Phases

 

We manage all aspects of first-in-human, first-in-patient, proof-of-pharmacology, proof-of-concept, dose-finding and registration clinical trials.

 

Services

 

  • Drug development program consultancy
  • Study design and protocol writing
  • Project management
  • Clinical operations
  • Medical writing
  • Pharmacovigilance
  • Data management and statistics
  • Quality management system development

Recent successes

InterEuropa Clinical Research has participated recently in a phase II clinical trial running on 3 continents. The clinical trial involved the recruitment of patients with acute coronary syndromes in selected interventional cardiology centers. A number of challenges have been successfully overcome and timely patient recruitment and patient adherence to a busy study drug administration and evaluation schema have been achieved.

 

InterEuropa Clinical Research has successfully completed a proof-of-concept clinical trial in an ultra-rare disease indication. Although the number of needed subjects was low, due to the rare prevalence of the disease sites in 4 countries on 2 continents had to be opened. The correct identification of the suitable sites and investigators as well as the capacity of understanding the scientific complexity of the medical condition have been the key to success of this project.

 

Zenith has recently been instrumental in helping a biotech company in achieving a major milestone – the completion of a phase I/II trial of its lead cancer vaccine. Services have included:

  • Management of CRAs CROs and other third-party suppliers
  • Preparation, review and approval of trial document
  • Set-up and review of Quality Management system
  • Overall clinical operations oversight

 

Zenith’s relationship with this client is continuing with preparatory work for a follow-on international phase II trial with their lead product.

 

Zenith has recently provided consultancy services to a biopharmaceutical start-up that focuses on the development of innovative immunotherapeutic platforms. Working closely with the sponsor ensured timely initiation of the critical component of the product development work.

 

Services included:

  • Ensuring the successful approval of the first commercially sponsored protocol and subsequent enrolment
  • Development of the protocol and participant information documents
  • Site identification, selection and contract negotiation
  • Development and roll-out of the protocol procedures.

 

Syntax for Science has recently conducted a phase I clinical trial. Logistic issues made impossible to receive full concentration data which was required for selecting the next dose. Our Biostatistics team incorporated compartmental analysis with mixed models to estimate half-life parameters using partially incomplete data. The Dose Escalation Safety Committee was able to decide about the next dose avoiding study delays. The decision was later confirmed with complete data and proved to be correct.

 

Syntax for Science has been working during the last 4 years with a top-10 biotechnology company to solve one of their problems: identification of patients with a rare disease. Syntax for Science was able to conduct a series of studies to improve knowledge and stablish methodologies for screening and diagnosis of patients. Our Data Management group faced the challenge to obtain data distributed globally. Each study supposed a new challenge from having to harmonize and validate retrospective data from several sources, to organize electronic data capture systems for prospective studies with a large number of centers and low recruitment. Our Biostatistics team was able to develop a series of tools for screening and diagnosis which facilitated the identification of patients.