We provide full CRO services covering each step of a clinical investigation, from First In Human (FIH) to observational registries

We offer full-service CRO assistance and clinical digital solutions for all clinical trials’ needs, with focus on medical devices, in vitro diagnostics, pharmaceuticals and food supplements. Our in-depth knowledge of regulatory and clinical trials’ requirements across Countries, enables a smooth and fast market access, while ensuring regulatory compliance with the utmost care and consideration for the patient.

Over the year, we built unique expertise on medical devices: Medical Device and IVD Regulations represent an important paradigm shift where the patient benefit is at the center and for this scope medical device manufacturers are requested to prove the clinical benefit of their medical devices compared to the current State of the Art.

We support medical device companies to fulfill MDR and IVDR clinical and performance requirements by designing pre-market studies, post-market clinical plan and real world data collection programs to generate and collect strong clinical data in support of the safety and performance of medical devices either for obtaining market approvals from Regulatory Authorities or for CE-mark maintenance.

We provide full CRO services covering each step of a clinical investigation, from First In Human (FIH) to observational registries

We offer full-service CRO assistance and clinical digital solutions for all clinical trials’ needs, with focus on medical devices, in vitro diagnostics, pharmaceuticals and food supplements. Our in-depth knowledge of regulatory and clinical trials’ requirements across Countries, enables a smooth and fast market access, while ensuring regulatory compliance with the utmost care and consideration for the patient.

Over the year, we built unique expertise on medical devices: Medical Device and IVD Regulations represent an important paradigm shift where the patient benefit is at the center and for this scope medical device manufacturers are requested to prove the clinical benefit of their medical devices compared to the current State of the Art.

We support medical device companies to fulfill MDR and IVDR clinical and performance requirements by designing pre-market studies, post-market clinical plan and real world data collection programs to generate and collect strong clinical data in support of the safety and performance of medical devices either for obtaining market approvals from Regulatory Authorities or for CE-mark maintenance.

Clinical Services

We offer high quality and customized CRO services

With extensive experience with all types of clinical trials, from First In Human to pivotal pre-market studies, from post-market clinical follow up activities to retrospective studies and observational registries, we are capable of aligning with your business goals, adjusting to your needs of time and budget, alongside with regulatory compliance.

Our consolidated connections in the industry allow us to find the most suitable fit for your needs and to be flexible with emerging trends in submission procedures. We also offer “clinical trials rescue programs” to help companies to correct poorly designed clinical trials.

We are not just another CRO, we are your collaborative proactive partner

Our proactive approach has helped us in providing the best support to our clients. Arising issues are faced and resolved in nearly real-time, whilst never loosing focus on the study’s primary objective. This approach allows to maximize the cost-effective use of company’s resources in achieving their goals.

Clinical
Services

Clinical Services

We offer high quality and customized CRO services

With extensive experience with all types of clinical trials, from First In Human to pivotal pre-market studies, from post-market clinical follow up activities to retrospective studies and observational registries, we are capable of aligning with your business goals, adjusting to your needs of time and budget, alongside with regulatory compliance.

Our consolidated connections in the industry allow us to find the most suitable fit for your needs and to be flexible with emerging trends in submission procedures. We also offer “clinical trials rescue programs” to help companies to correct poorly designed clinical trials.

We are not just another CRO, we are your collaborative proactive partner

Our proactive approach has helped us in providing the best support to our clients. Arising issues are faced and resolved in nearly real-time, whilst never loosing focus on the study’s primary objective. This approach allows to maximize the cost-effective use of company’s resources in achieving their goals.

Clinical
Services

 

We own strong expertise across therapeutic areas

Our structured and multidisciplinary regulatory team has a broad focus across therapeutic areas with expertise in a wide range of medical fields.

  • Cardiology/cardiovascular
  • Hematology
  • Gastroenterology
  • Dermatology
  • Rheumatology
  • Ophthalmology
  • Dental and oral care
  • Aesthetic medicine
  • Gynecology
  • Proctology
  • Urology
  • ENT
  • Respiratory
  • Oncology
  • Orthopedics

We own strong expertise across therapeutic areas

Our structured and multidisciplinary regulatory team has a broad focus across therapeutic areas with expertise in a wide range of medical fields.

  • Cardiology/cardiovascular
  • Hematology
  • Gastroenterology
  • Dermatology
  • Rheumatology
  • Ophthalmology
  • Dental and oral care
  • Aesthetic medicine
  • Gynecology
  • Proctology
  • Urology
  • ENT
  • Respiratory
  • Oncology
  • Orthopedics

Clinical Services

We offer turn-key clinical development services

We support our clients for all clinical trials’ needs,
and our clinical services include:

  • Clinical study design
  • Site(s) election
  • Study Start-Up
  • Clinical Project Management
  • Medical writing and preparation of study documentation as per ISO 14155
  • eTMF
  • Support for the Investigational Medicinal Product Dossier (IMPD)
  • Biostatistics, data management and CRF/e-CRF
  • Monitoring visits on-site and remote
  • Real-World Evidence (RWE) registries
  • Rescue studies
Clinical
Services

Clinical Services

We offer turn-key clinical development services

We support our clients for all clinical trials’ needs,
and our clinical services include:

  • Clinical study design
  • Site(s) election
  • Study Start-Up
  • Clinical Project Management
  • Medical writing and preparation of study documentation as per ISO 14155
  • eTMF
  • Support for the Investigational Medicinal Product Dossier (IMPD)
  • Biostatistics, data management and CRF/e-CRF
  • Monitoring visits on-site and remote
  • Real-World Evidence (RWE) registries
  • Rescue studies