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Clinical Trial

Services

Our approach

Medical devices are a vital part of modern clinical trials. PRO VITA offers a comprehensive range of services dedicated to the clinical trials industry, both CROs and sponsors.
We cover every aspect of clinical trials associated with the use of medical devices.

Our key areas of expertise include:

  • pneumonology
  • allergology
  • ENT
  • neurosurgery (brain and spine).

We can also manage projects from other medical fields.

Find out more

We are:

EXPERT

Our experienced, GCP-accredited clinical trials team of medical doctors and engineers has a deep understanding of medical devices and clinical trial processes.

INDEPENDENT

We cooperate with various manufacturers but retain the right to choose the optimum solution for each clinical trial. This makes us a unique, highly specialised partner for CROs and sponsors, not only as an equipment provider, but also as an experienced (and again independent) medical device consultant.

RELIABLE

All our procedures are GCP compliant and validated in real clinical environments (by our own Clinical Trials Evaluation Centre).

FLEXIBLE

Our R&D department allows us to efficiently customise existing serial production devices for aspecific trial needs.

EFFECTIVE

Continual collaboration with medical scientists and experienced clinical sites enables us to provide a dedicated, effective and optimised solution for each project.

CONNECTED

We use state-of-the-art, customisable and scalable IT infrastructure based on the world’s most trusted and secure cloud platform. All project data are immediately at our partners’ fingertips in the desired format.

DIRECT

A dedicated project manager coordinates each project from beginning to end. We’re located in the heart of Europe with subsidiaries in Germany and Poland.

INNOVATIVE

Innovation is our passion – not to mention our company’s mission. We strive to provide the most innovative solutions for the clinical trials industry, continually introducing new, modern tools to provide outstanding service. Besides traditional face-to-face meetings and training, we specialise in dedicated tele-medical training, instructional videos, interactive SOPs and remote maintenance.

Services

Services for clinical trials (CROs and sponsors):

  • pre-study clinical feasibility services
  • medical device consulting (before, during and after clinical trial)
  • independent choice and clinical validation of PFT instruments
  • medical device/PFT equipment rental
  • comprehensive clinical training services
  • 24/7 clinical trial logistics
  • state-of-the-art 24/7 support and maintenance
  • direct-to-patient services.

What else can we do for you in a clinical trial?

Drop us a line

Expertise in Pulmonary Function Testing (PFT)

Since 2001, PRO VITA has specialised in pulmonary function testing solutions, providing a complete range of diagnostic devices, from basic devices up to the most advanced, complex PFT systems.

PRO VITA works closely with the leading pulmonary diagnostic manufacturers but remains independent, offering the right solution for every clinical trial and project.

Our independency, unique experience and in-depth medical knowledge results in incomparable, high-quality services for pulmonary clinical trials.

Our team has immediate access to real clinical environments thanks to our close collaboration with leading pulmonary professionals and medical universities. This allows the efficient, proactive creation and verification of each diagnostic solution.

Meet our unique service

We offer:

  • A full range of top-class, standardised pulmonary diagnostic devices to support any multi-centre clinical trial
  • Flexible, trial-specific software and hardware customisations from our internal R&D department
  • Customised, trial-specific standard operating procedures (SOPs)
  • Protocol-specific training sessions, webinars and workshops
  • Over-reading services from renowned pulmonary professionals (adult and paediatric)
  • Data transmission and collection
  • An industry-leading, always-available Clinical Trial Support and Service (CTS1) Team*

*With our CTS1 Team, you can be sure our experts are always available.

Years of clinical trial experience

Projects completed

/ 7

Support & service availability

We can

meet any challenge related to pulmonary function testing.

Increase level of confidence before your clinical trial starts

PFT Clinical Feasibility Study

A challenge in every trial protocol is finding the optimal diagnostic methods for a specific group of patients.

Key to a study’s success is optimising patient workload and compliance during the trial.

We operate our own pulmonary clinical trial centre with more than 20 years of experience and dozens of completed projects, specialising in asthma, COPD and other respiratory diseases.

Together with our expert team of engineers, we offer an industry-leading, comprehensive analysis of the trial protocol. We perform our analysis on a pilot group of patients who comply with the protocol and we examine every aspect of their workload associated with the trial.

We then produce a comprehensive pre-study feasibility report summarising all the diagnostic and reporting procedures. The report covers patient workload and satisfaction, clinical site workload and a summary of the challenges, difficulties and potential threats to the study’s overall feasibility.

Supported PFT modalities include:

  • Spirometry
  • Peak flow
  • Body plethysmography
  • DLCO/single breath, intra breath, steady state
  • Challenge testing
  • MIP/MEP/SNIP
  • Forced oscillation technique
  • Nitrogen washout systems; FRC N2/lung clearance Index
  • Fractional exhaled nitric oxide (FeNO) bronchial, nasal, alveolar
  • Rhinomanometry and acoustic rhinometry
  • Other PFT modalities*

*If you need another PFT modality, please do not hesitate to contact us.

We know

service quality and responsiveness are crucial during clinical trials.

Clinical trial – Quick contact guide

Let’s discuss your project today

Don’t hesitate to contact us directly if you believe that your project may benefit from our clinical trial services.
We are aware that clinical research is complex and time-consuming. However, we do our best to make our communications as efficient as possible.

We recommend three simple steps for starting a dialogue between us:

  1. Send an email to office@provitagroup.com briefly describing your project.
  2. We will reply with a proposed time for a ∼30min conference call with our dedicated expert.
  3. Based on the above, we will prepare a custom plan of our clinical services.
Partners.

Meet our core Partners