Sphera Clinical Research Knowledge Empowers Discovery

Sphera Clinical Research is a full-service Contract Research Organisation (CRO) specialising in clinical investigations of medical devices and in vitro diagnostic medical devices (IVDs).

We combine scientific expertise, operational excellence, and regulatory insight to accelerate innovation and bring safe, effective medical devices to patients worldwide. We collaborate with sponsors of all sizes – from early-stage innovators to established global manufacturers – providing tailored clinical solutions that ensure quality, regulatory conformity and confidence throughout the lifecycle of each project.

Partner with us to turn knowledge into discovery.
About us

Driven by Knowledge. Defined by Expertise.
Sphera Clinical Research was founded by experienced professionals committed to excellence in the design and conduct of clinical investigations for medical devices and in vitro diagnostic medical devices.
We combine the agility and responsiveness of a boutique CRO with the quality systems, scientific rigour and operational reliability expected from leading global research organisations.

Our leadership team has extensive experience in the management of complex, multi-country clinical investigations conducted under MDR, IVDR and FDA regulatory frameworks. This depth of understanding ensures that each project is delivered with scientific precision, regulatory conformity and the highest standards of patient safety.

Our Core Values:

Knowledge empowers discovery – our guiding principle
Integrity and transparency at every stage of the clinical investigation process.
Collaboration that fosters long-term trust with sponsors and investigators.
Quality without compromise, from early study planning through to final reporting and regulatory submission.
Services

End-to-End Clinical Solutions for Medical Devices and IVDs.
Sphera Clinical Research provides a comprehensive suite of services across the entire clinical development pathway — from concept and feasibility through to regulatory approval and post-market evaluation.Our approach is flexible, transparent and closely aligned with the regulatory requirements of MDR and IVDR.

Clinical Strategy & Planning
  • Feasibility assessments and regulatory-landscape analysis
  • Development of Clinical Investigation Plans and study design optimization
  • Risk assessment and development of mitigation strategies
  • Regulatory strategy, regulatory submissions, and authority interactions
Clinical Operations
  • Site identification, qualification and initiation
  • Project Management, oversight of investigators, research teams and Clinical Research Associates
  • Development of participant-recruitment and retention strategies
  • On-site and remote monitoring, including source-data verification
Data, Biostatistics & Medical Writing
  • Data-management systems tailored to medical device and IVD investigations
  • Creation of Case Report Forms (CRFs) consistent with the approved CIP
  • Statistical planning and sample size determination,
  • Statistical analysis and interim data reviews,
  • Comprehensive medical-writing support, including:
    • Participant Information Sheets and Informed Consent Forms (PIS/ICFs)
    • Patient materials
    • Clinical Investigation Reports (CIRs)
    • Scientific publications and articles
    • Standard Operating Procedures (SOPs)
Regulatory & Quality Support
  • Guidance on device-specific regulations (MDR, IVDR, FDA)
  • Quality-management guidance, including compliance audits and training
  • Preparation for inspections
Specialised Capabilities
  • Pilot and pivotal clinical investigations confirming device safety and performance
  • Post-Market Clinical Follow-up (PMCF) studies
  • Performance studies
  • Expertise in digital health technologies and Software as Medical Device (SaMD)
  • Real-world evidence (RWE) and post-approval research
Experience / Portfolio

Proven Track Record in Medical Device and IVD Clinical Research.
With over 20 years of clinical-research experience, Sphera Clinical Research has supported more than 50 clinical investigations involving medical devices and IVDs across Europe and global markets.Our portfolio encompasses a broad range of device classes and clinical indications — extending from wound-care technologies and cardiovascular systems to neurological devices and life-saving oncological innovations.
We provide complete operational and regulatory oversight, from study design and submission through to site activation, monitoring, data management and final reporting.

Therapeutic Experience Overview:

Dermatology & Wound Care

Device Types:

  • Advanced wound dressings (including various wound dressings for chronic and acute wounds)
  • Hydrogel dressings, including hydrogels containing amino acids
  • Dressings with silver (Ag), PHMB and charcoal dressing and rope
  • Cold-plasma devices used for wound treatment
  • Wound-irrigation devices
  • Pads and accessories for wound debridement

Clinical Indications:

  • Venous leg ulceration and infected venous leg ulceration
  • Pressure ulceration
  • Chronic wounds of different or complex origin
  • Acute wounds of different origin (including traumatic and post-surgical)
  • Infected and non-infected wounds of various origin
  • Dermatological defects requiring enhanced wound healing

Cardiology

Device Types:

  • Heart valves for aortic valve replacement and aortic stenosis
  • Cardiac resynchronisation therapy (CRT) systems, including Multipoint Pacing systems
  • High-voltage and implantable cardioverter-defibrillator (ICD) leads for patients undergoing MRI
  • Cardiac rhythm-management systems (for bradycardia/tachycardia) undergoing MRI
  • Substance-eluting vascular scaffold systems and substance-eluting coronary stent systems

Clinical Indications:

  • Heart failure requiring resynchronisation therapy
  • Arrhythmias, including bradycardia and tachycardia
  • Aortic stenosis and conditions requiring aortic valve replacement
  • Ischaemic heart disease

Oncology

Device Types:

  • Implantable spacers used in prostate-cancer radiotherapy
  • Imaging systems used during wide local excision
  • Diagnostic equipment for breast cancer
  • Thermographic examination equipment used in breast pathology and mastopathy evaluation
  • Microspheres with radioactive substances
  • Nanoparticles with radioactive substances

Clinical Indications:

  • Prostate cancer
  • Breast cancer and breast pathology (including breast mastopathy)
  • Melanoma
  • Squamous cell carcinoma of the oral cavity or oropharynx
  • Hepatocellular carcinoma
  • Metastatic colorectal carcinoma of the liver
  • Solid tumours requiring local radiotherapy planning and intraoperative margin assessment

Neurology

Device Types:

  • Deep brain stimulation (DBS) systems and related neuromodulation implants
  • In vitro diagnostic assays used in the assessment of acute ischaemic stroke

Clinical Indications:

  • Parkinson’s disease
  • Acute ischaemic stroke

Urology & Endocrinology

Device Types:

  • Intermittent urinary catheters
  • Micropump infusion systems for insulin delivery in type I diabetes

Clinical Indications:

  • Problems with urination and urinary-tract dysfunction requiring catheterisation
  • Type I diabetes requiring continuous insulin infusion

Critical Care & Infectious Disease

Device Types:

  • Catheters implanted into the central vein, including central venous catheters (CVCs) used in haemodialysed and critically ill patients
  • Antimicrobial susceptibility-testing systems

Clinical Indications:

  • Conditions requiring central venous access, including haemodialysed patients and patients in intensive or critical care
  • Bacterial inflammations and infections requiring microbiological susceptibility testing

Aesthetic Medicine & Soft-Tissue Treatments

Device Types:

  • Injectable adipocytolytic solution for minimally invasive adipose-tissue reduction
  • Dermal fillers for soft-tissue augmentation and contouring (targeting lips, nasolabial folds and cheeks/mid-face)

Clinical Indications:

  • Localised adipose-tissue accumulation requiring non-surgical reduction and contour improvement
  • Aesthetic indications including lip enhancement, correction of nasolabial folds (NLF) and cheek or mid-face volume restoration or enhancement

Geographic and Operational Scope

Our experience extends across Europe and international multicentre networks, with strong collaboration between sponsors, investigators and regulatory authorities.
Our operational involvement typically includes:

  • Comprehensive medical writing
  • Preparation and submission to Ethics Committees and Competent Authorities
  • Site and investigator contracting
  • Full on-site and remote monitoring, including CRA oversight
  • Project management and sponsor communication
  • Data management, eCRF configuration and biostatistical support

Our long-standing partnerships with leading pharmaceutical and biotech sponsors demonstrate the trust placed in our ability to deliver accuracy, compliance and excellence throughout every phase of clinical research.
Each clinical investigation is conducted with a firm commitment to quality, regulatory alignment and the guiding belief that Knowledge Empowers Discovery.

Why Sphera?

A Specialist CRO with Global Standards.
Partnering with Sphera Clinical Research means choosing a CRO with a deep understanding of the unique scientific and regulatory challenges associated with medical device and in vitro diagnostic medical device (IVD) development. We combine the precision and robustness expected of a major international CRO with the agility, attentiveness and partnership-driven ethos of a specialised research organisation.

Let’s Empower Discovery Together!
Are you ready to discuss your next clinical investigation?
Our experts are here to design, manage, and deliver studies that help you navigate the complex landscape of medical device regulation.

What We Offer:
Device-centric expertise a focused approach tailored specifically to medical devices and IVDs, rather than a generic one-size-fits-all CRO model
Direct engagement with senior project leaders, ensuring consistent oversight and expert decision-making
Efficient communication and accelerated responsiveness, enabling smooth study progress and reduced operational delays
Proven competence within MDR/IVDR regulatory environments, with experience across a broad spectrum of device classes and risk categories
High-quality, cost-effective operations trusted by global medical technology and biotechnology sponsors
References
Connect with us to begin your next clinical success!

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We reserve the right to update this Privacy Policy where necessary. Any amendments are introduced in order to ensure continued compliance with the requirements of the European Regulation on the Protection of Personal Data (GDPR).

Information on the processing of personal data

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Personal data are processed for the purposes of business communication and may be shared with entities cooperating with Sphera Clinical Research, solely to the extent necessary to perform services or process orders. Personal data will be processed until consent for their processing is withdrawn.

If you do not consent to the processing of your personal data, please notify us accordingly; your data will then be removed from our records without undue delay. You also have the right to lodge a complaint with the President of the Personal Data Protection Office if you believe that the processing of your personal data infringes applicable data protection regulations.

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