Principal Investigator cooperating with Sphera Clinical Research
I am writing in my capacity as a Principal Investigator cooperating with Sphera
Clinical Research (SCR) to confirm and summarise our collaboration in seventeen (17)
clinical trials involving medical devices.
I have been collaborating continuously with Sphera Clinical Research, under the
management of Ms Patrycja Buczak, since 2010.
The studies primarily focused on dermatology and wound management and included
investigations of advanced wound dressings, including specialised and combination
products for acute and chronic wounds of different origin, as well as various wound
care products for both acute and chronic indications.
From the Principal Investigator’s perspective, cooperation with Sphera Clinical
Research has consistently been characterised by excellent organisation, high
clinical trial proficiency, and a strong commitment to study quality and patient
safety. SCR demonstrated a thorough understanding of the regulatory and operational
specificities of medical device clinical trials, together with a pragmatic and
solution-oriented approach to study conduct.
Of particular importance from the investigative site’s perspective has been the
exceptional accessibility and responsiveness of the SCR team. Communication with SCR
was available almost around the clock when needed, allowing for rapid clarification
of issues and immediate support in urgent situations. Their professional approach,
quick reaction times, and practical assistance in problem-solving have been
invaluable in ensuring uninterrupted study conduct and effective site operations.
Across the completed studies, patient recruitment was achieved efficiently and, in
the majority of cases, completed ahead of the anticipated timelines, reflecting
realistic feasibility planning, close cooperation with investigative sites, and
proactive recruitment management. For the ongoing studies, recruitment has
progressed in a structured and well-controlled manner.
Throughout our collaboration, Sphera Clinical Research has shown particular care for
data integrity, protocol compliance, and transparent communication with
investigators. Their cooperative attitude, reliability, and respect for the
investigator’s role have significantly contributed to the smooth conduct and high
quality of the studies.
Based on my direct experience across seventeen clinical trials, I can confidently
confirm that Sphera Clinical Research is a highly competent, reliable, and
quality-driven CRO. I would readily recommend SCR to sponsors seeking a partner with
proven operational expertise, efficient recruitment performance, and a genuinely
investigator-focused approach.
Principal Investigator