First-to-Patient Trials with inhaled drugs
At NUVISAN, we have strong experience and expertise in many of the unique aspects that define early clinical research with respiratory and inhaled drug products. We help our customers navigate the complex challenges of respiratory clinical trials through our experienced clinical development team and our deep relationsship to scientific experts as well as key opinion leaders.
When conducting clinical safety trials with inhaled drugs, there are some specific aspects to consider, such as avoidance of contamination, correct inhalation technique, PK blood samples in tight time intervals shortly after inhalation, and investigation of local tolerability which often requires the prior identification of patients with hyper reactive bronchial system. But there are more specific points to consider for which our study staff is experienced and qualified.
Flow Profile/PIF Studies
Flow-Profile Studies are a special class of medical device studies. Regulatory Agencies usually request at least one Flow-Profile Study for the Marketing Authorization of a novel inhaler device to characterize the inspiratory flow maneuvers in the target patient populations compared to healthy subjects. A reduced study design with the endpoint Peak Inspiratory Flow (PIF) may be sufficient. The characteristics of the novel inhaler system are usually compared to a marketed reference inhaler system. This is a quite specific type of medical device study which requires being able to deal with the technical requirements of flow measurements and to recruit target patient populations, such as severe asthma or COPD, or even children in case of pediatric asthma. A track record of successfully conducted flow-profile studies is available at NUVISAN. All these studies were conducted in a short period of time. As always, offer full-service solutions including Clinical Investigational Plan (CIP) writing, clinical conduct, evaluation, and reporting. Moreover, NUVISAN’s project managers are experienced in the management of the submission procedure for medical device studies and can deal with some of the special regulatory features required for this study type.
Inhaled BE trials in patients
The development of generics for inhaled formulations can be challenging since the device technology and aerosol characteristics have a significant impact on the lung deposition of the active component. A generic drug product must be bioequivalent in terms of rate and extent of absorption of the active pharmaceutical ingredient. Determination of clinical bioequivalence (BE) of inhaled drug products can be split into three approaches: 1.) lung deposition as determined by pharmacokinetics (with charcoal block), 2.) demonstration of therapeutic equivalence (usually requested for US registration), and 3.) lung deposition as determined by imaging technology. Pharmacokinetic studies with inhaled drugs are usually the basis of any inhaled generic development. Pilot PK studies are typically conducted in a first step for device optimization. Marketing Authorization of inhaled generics in the EU is usually based on pharmacokinetic BE studies. In addition to the assessment of inhaled BE with charcoal block, Regulatory Agencies often ask for another study arm without charcoal block to make sure systemic exposure is also comparable for safety reasons. That means inhaled BE studies are often large-scale studies, and large cohorts should be investigated to streamline the study conduct. Moreover, it is essential that these clinical trials are conducted in good quality in terms of inhalation, accurate timing of PK blood samples, and prevention of contamination.
NUVISAN is your expert CRO for inhaled BE studies and can also give valuable advice regarding the optimization of the study design.
Clinical Management and Monitoring Late Phase Oncology Studies in Latin America
Our geographic footprint facilitates a significant presence in the leading ´Latin American (LATAM) market, combined with well-established affiliate operations, thereby covering a total of 10 countries with dedicated staff.
NUVISAN LATAM has 20 years of oncology drug development expertise in the region. Our project approach and processes are tailored to the specific needs of oncological trials.
NUVISAN LATAM offers tailored concepts across all key therapeutic areas with particular expertise not only in pivotal Phase II/III trials, but also in late-phase approaches such as observational studies, as well as regional and national projects.
We ensure that our clinical monitors are always up to date with local and international standards and we, as the majority of our partners, are members of local clinical research associations in their respective regions.
The clinical monitoring team is designed to closely work with the project management team in order to ensure that your study is executed precisely. Monitors are the representatives of NUVISAN and your study towards the investigators. This is why we assure best communication skills and performing quality checks on the investigator site frequently. Having a good relationship is one of the best motivations for investigators to follow the recruitment plan as scheduled.