Clinical Trial Services

A mid-size company providing the advantages of flexibility, responsiveness, and accountability.

For clinical trials and development, we offer clinical operations, medical writing, regulatory requirements, a central laboratory, data management, and biostatistics services. With Iris Pharma, you can mix-and-match stand-alone services or choose global support to test new ocular drugs and devices in humans during clinical development.

Clinical Operations

Iris Pharma’s clinical operations staff includes experienced project leaders and trained Clinical Research Associates (CRA). Our staff excels at all stages of study operations:

  • Feasibility and risk analysis
  • Investigation sites recruitment and qualification. We select the most appropriate clinical sites from our expansive network of European ophthalmologists.
  • Project management
  • Pre-study phase and site training
  • Investigator and hospital contracts
  • Study monitoring according to Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines. 
  • Patient retention programs that inform and engage patients to ensure they complete the trial
  • Investigator meetings and newsletters
  • Clinical supplies management
  • Hospital and investigators' fee management
  • Safety surveillance and pharmacovigilance

Iris Pharma's project leaders are the study managers and also the sponsor's principal contact person. They remain responsible throughout the evaluation phase and supervise the study schedule up to the production of the final report. The clinical research associates ensure the rapid generation of reliable and high-quality clinical data.

 Access to our proven clinical operations staff to accelerate the drug development process.

Medical Writing

Iris Pharma’s medical writers include staff with experience as ophthalmologists, pharmacists, scientists, and marketing experts, in addition to renowned external medical writing partners. We maintain close ties with international opinion leaders in ophthalmology and pharmacology as well. 

The writing and editing services we offer our clients include:

  • Protocols and study summaries
  • Investigator brochures
  • Investigational Medicinal Product Dossier (IMPD)
  • Design of case report forms (CRFs) and transcription to electronic case report forms (eCRFs) if required
  • Design of patient diaries
  • Clinical study reports
  • Publicationsand posters

 

 From writing protocols to clinical study reports, our medical writing team ensures the success of a project from start to finish.

 

Regulatory Affairs

Multinational clinical trials offer a variety of advantages, such as accelerating patient recruitment and yielding results that are more generally applicable across health care settings and geographic areas.

Iris Pharma alleviates the difficulties of leading a multinational trial by coordinating:

  • Submissions to competent authorities
  • Assessments of data for suitability for Clinical Trial Authorizations (CTA) and registration for phase 1 through 4 clinical trials
  • Submissions to ethics committees
  • Declaration of expeditable serious adverse events (SAEs) in the scope of clinical trials to the regulatory authorities (via our preferred provider)
  • Assistance with drug supply and labeling

All activities are performed under the European clinical trial directive (2001/20/CE) and local laws.

 

 Last year, Iris Pharma facilitated 143 regulatory submissions and approvals across 27 countries in Europe.

Central Laboratory

A single partner for clinical trials and a central laboratory give our clients the benefit of real-time, integrated data from around the globe. To facilitate this, we help with the following services for all phases of ophthalmic clinical trials:

  • Sample kit preparation
  • Sample collection and logistics
  • Clinical laboratory testing in compliance with Good Laboratory Practice (GLP) requirements in our own laboratory in La Gaude, France
  • Analytical methods in rare ocular matrices and tissues.
 

 

Data Management & Statistics

Iris Pharma’s approach is to provide our clients with cost-effective, secure, and regulatory-compliant clinical biometry solutions. According to the requirements of a particular study, we select the most effective subcontracting solution among our different partners, consisting of highly qualified and experienced data managers and statisticians.

We can collect data in a traditional paper Case Report Form (CRF), or from an electronic Case Report Form (eCRF). In the case of eCRF, electronical clinical data capture (EDC) is performed and clinical trial data are electronically submitted to a remote database, allowing real-time data availability.