CLINICAL TRIALS
From feasibility to post-market, full clinical trial support.
CLINICAL TRIALS
From feasibility to post-market, full clinical trial support.
With direct access to senior experts and an agile, responsive model, we shorten timelines and keep your trial inspection ready.
Clinical Operations
Start-ups and growing companies often face resource constraints when navigating MDR 2017/745 and EN ISO 14155.
At Veron Scientific, our Clinical Operations team provides the structure and oversight to keep studies moving efficiently and compliantly.
Clinical Operations sits at the heart of every trial, acting as the central link between sites, monitors, regulatory, data, safety, and vendors.
We manage this complexity on your behalf, ensuring smooth communication, timely execution, and inspection-ready documentation, including full Trial Master File (TMF/eTMF) and Investigator Site File (ISF) management.
With end-to-end oversight from feasibility through to close-out, we align stakeholders, mitigate risks, and keep trials on track.
Regulatory Affairs Solutions
Navigating complex global frameworks is critical to trial success. Our Regulatory Affairs team supports biotech, pharma, and medtech companies from early feasibility through to market authorisation and post-trial obligations. We streamline submissions, accelerate approvals, and ensure full compliance with EU MDR (2017/745), EN ISO 14155, ICH-GCP, and FDA/EMA requirements.
Our Services
Regulatory Strategy & Consulting
– Strategic guidance on regulatory pathways for drugs, biologics, medical devices, and combination products.
– Feasibility assessments and study planning to optimise timelines and approval success.
Submissions & Lifecycle Management
– Preparation and submission of CTAs (via CTIS) and dossiers for Ethics Committees and Competent Authorities.
– CMC (Chemistry, Manufacturing & Controls) support for small molecules and biologics; clinical evaluation documentation for devices.
– Trial registration on global portals (e.g. ClinicalTrials.gov, EU CTR).
– Submission of amendments, annual reports, and responses to authority queries.
– Review of packaging, labelling, and essential documents for compliance.
– Site contract and budget negotiation support.
Publishing & e-Submissions
– Fully compliant formatting and electronic submission via CTIS, CESP, PRISM, Sugam, and other global systems.
Why It Matters
Our regulatory experts act as an extension of your team, bridging science and compliance. Whether providing full-service support or targeted input, we reduce delays, simplify complexity, and ensure your trial is inspection-ready from start-up to approval.
Study Management
We manage every stage of the clinical trial lifecycle, from feasibility and first-in-human studies to post-market clinical follow-up (PMCF). Each project is overseen by a dedicated study manager, coordinating expert teams across monitoring, site management, regulatory, safety, and vendor functions.
Our multilingual staff bring cross-disciplinary expertise and ensure alignment across stakeholders, while maintaining compliance with EU MDR, EN ISO 14155, ICH-GCP, and global regulations. This integrated model keeps studies moving efficiently, transparently, and inspection-ready.
Clinical Monitoring & Site Management
Effective monitoring requires both adaptability and a rigorous eye for detail.
Our experienced CRAs offer a unique combination of in-depth regulatory knowledge and hands-on expertise in complex protocols. Comprehensive site oversight from selection to close-out, ensuring patient safety, data integrity, and trial compliance with a smart balance of on-site and remote oversight, delivering inspection-ready trials across biotech, pharma, and medtech
Our Monitoring Expertise
- Site Selection & Initiation – qualification, activation, and staff training on study protocols and procedures.
- On-Site & Remote Oversight –
• In biotech and pharma: experienced CRAs with deep regulatory knowledge.
• In medtech: Field Clinical Engineers (FCEs) with hands-on technical expertise and full in-house engineering backup. - Risk-Based Monitoring – blending on-site presence with remote oversight to safeguard data quality, patient protection, and site performance.
- Regulatory Compliance – inspection-ready documentation aligned with ICH-GCP, EU MDR, EN ISO 14155, and FDA/EMA requirements.
- Global Reach – senior monitors and FCEs with experience across hospitals, specialised research centres, and clinical research units (CRUs).
We don’t just tick boxes; our CRAs and FCEs act as consultants and problem-solvers, helping sites and sponsors resolve challenges quickly to keep studies on track. With Veron Scientific, you gain clarity, compliance, and confidence at every stage of monitoring.
Quality Assurance
We ensure every process, document, and deliverable meets international standards.
Our QA services cover internal systems and vendor oversight, trial master file (TMF) audits, site audits, and inspection readiness reviews. By applying independent quality checks across the trial lifecycle, we help sponsors maintain compliance with ICH-GCP, EU MDR, EN ISO 14155, and FDA regulations, while ensuring data integrity and patient protection.
Medical Writing
Our expert writers deliver clear, accurate, and regulatory-compliant documents, from protocols and informed consent forms to study reports and scientific publications. Every document is created to support smooth ethics approval, inspection readiness, and effective communication with regulators, investigators, and patients.
Clinical Trial Documents
We prepare and review essential trial documents with clarity and rigour, ensuring compliance with EN ISO 14155, EU MDR, ICH-GCP, MDCG guidance, and local regulations. Our writers work closely with Clinical Operations and Regulatory experts to make sure documents are both scientifically accurate and accessible to ethics committees, regulators, investigators, and patients.
Scientific Publications
We also support the preparation of peer-reviewed manuscripts and scientific articles, presenting study results in a structured, concise, and credible way that stands up to academic and industry standards.
Our Medical Writing Services
- Clinical Investigation Plans (CIP)
- Investigator’s Brochures (IB)
- Patient Information Sheets & Informed Consent Forms (ICF)
- Instructions for Use (IFU)
- Questionnaires & Patient-Facing Materials
- Recruitment Materials
- Clinical Study Reports (CSR)
- Clinical Overviews & Summaries
- Clinical Evaluation Plans & Reports
- Scientific Publications
With Veron Scientific, you gain clear, compliant, and inspection-ready documents that keep your trials on track and your results ready for review and publication.
Vendor Management
Oversight of all key vendors to ensure seamless coordination and quality delivery.
Clinical trials depend on a network of specialised providers — from central labs and IRT systems to imaging vendors and IMP supply. At Veron Scientific, we take responsibility for selecting, qualifying, and managing vendors, ensuring they meet your study’s technical, regulatory, and operational requirements.
Our Services
- Vendor Selection & Qualification – rigorous assessment of vendors (labs, IRT/RTSM, imaging, IMP manufacturers, couriers, etc.) to ensure quality, compliance, and fit for purpose.
- Contract & Budget Support – negotiation and oversight to secure value and maintain transparency.
- Ongoing Oversight – performance tracking, KPI monitoring, and issue resolution to keep deliverables on time and in scope.
- Compliance Assurance – ensuring vendors adhere to ICH-GCP, EU MDR, EN ISO 14155, and global regulations.
- Single Point of Contact – simplifying communication and accountability for sponsors by coordinating multiple providers through one team.
Clinical Audit
Independent clinical audits that secure compliance, data integrity, and inspection readiness.
Staying compliant means more than checking boxes; it means ensuring your data is reliable, your sites are inspection-ready, and your study can withstand scrutiny.
At Veron Scientific, we perform independent audits covering sponsors, CROs, sites, and systems, always aligned with EN ISO 14155 and international regulations. Our services include:
- Internal & CRO audits
- Trial Master File audits
- On-site & inspection readiness audits
With 100+ national and international audits completed, our senior auditors deliver clear reports and practical CAPAs, giving you confidence in compliance, data integrity, and overall study quality.
MedTech
Clinical trials in the MedTech industry are often more complex, involving product development, clinical support by specialists in operating theatres or cath labs, and follow-ups. Veron Scientific has decades of experience in medical devices, including pacemakers, stents, valve technologies, neuroprotection, and neuromodulation. Our clinical specialist team provides support in operating theatres or cath labs.
Biotech
We support biotech innovators from early feasibility through to pivotal trials, helping accelerate development while safeguarding compliance and data quality. Our tailored CCRC model provides direct access to senior experts and streamlined oversight.
Areas of expertise include:
• Early-phase, first-in-human studies
• Adaptive trial designs and innovative data strategies
• Regulatory submissions and inspection readiness
• Biometrics and data-driven trial management
Pharma
We work with pharma companies to design and deliver efficient, inspection-ready trials across global markets. With decades of combined experience, our teams bring regulatory depth, operational excellence, and reliable data insight.
Areas of expertise include:
• Phase I–III clinical development
• Oncology and haematology
• Autoimmune and inflammatory disorders
• Pharmacovigilance and safety management
Clinical Operations
Clinical Operations
Start-ups and growing companies often face resource constraints when navigating MDR 2017/745 and EN ISO 14155.
At Veron Scientific, our Clinical Operations team provides the structure and oversight to keep studies moving efficiently and compliantly.
Clinical Operations sits at the heart of every trial, acting as the central link between sites, monitors, regulatory, data, safety, and vendors.
We manage this complexity on your behalf, ensuring smooth communication, timely execution, and inspection-ready documentation, including full Trial Master File (TMF/eTMF) and Investigator Site File (ISF) management.
With end-to-end oversight from feasibility through to close-out, we align stakeholders, mitigate risks, and keep trials on track.
Regulatory Affairs Solutions
Regulatory Affairs Solutions
Navigating complex global frameworks is critical to trial success. Our Regulatory Affairs team supports biotech, pharma, and medtech companies from early feasibility through to market authorisation and post-trial obligations. We streamline submissions, accelerate approvals, and ensure full compliance with EU MDR (2017/745), EN ISO 14155, ICH-GCP, and FDA/EMA requirements.
Our Services
Regulatory Strategy & Consulting
– Strategic guidance on regulatory pathways for drugs, biologics, medical devices, and combination products.
– Feasibility assessments and study planning to optimise timelines and approval success.
Submissions & Lifecycle Management
– Preparation and submission of CTAs (via CTIS) and dossiers for Ethics Committees and Competent Authorities.
– CMC (Chemistry, Manufacturing & Controls) support for small molecules and biologics; clinical evaluation documentation for devices.
– Trial registration on global portals (e.g. ClinicalTrials.gov, EU CTR).
– Submission of amendments, annual reports, and responses to authority queries.
– Review of packaging, labelling, and essential documents for compliance.
– Site contract and budget negotiation support.
Publishing & e-Submissions
– Fully compliant formatting and electronic submission via CTIS, CESP, PRISM, Sugam, and other global systems.
Why It Matters
Our regulatory experts act as an extension of your team, bridging science and compliance. Whether providing full-service support or targeted input, we reduce delays, simplify complexity, and ensure your trial is inspection-ready from start-up to approval.
Study Management
Study Management
We manage every stage of the clinical trial lifecycle, from feasibility and first-in-human studies to post-market clinical follow-up (PMCF). Each project is overseen by a dedicated study manager, coordinating expert teams across monitoring, site management, regulatory, safety, and vendor functions.
Our multilingual staff bring cross-disciplinary expertise and ensure alignment across stakeholders, while maintaining compliance with EU MDR, EN ISO 14155, ICH-GCP, and global regulations. This integrated model keeps studies moving efficiently, transparently, and inspection-ready.
Clinical Monitoring & Site Management
Clinical Monitoring & Site Management
Effective monitoring requires both adaptability and a rigorous eye for detail.
Our experienced CRAs offer a unique combination of in-depth regulatory knowledge and hands-on expertise in complex protocols. Comprehensive site oversight from selection to close-out, ensuring patient safety, data integrity, and trial compliance with a smart balance of on-site and remote oversight, delivering inspection-ready trials across biotech, pharma, and medtech
Our Monitoring Expertise
- Site Selection & Initiation – qualification, activation, and staff training on study protocols and procedures.
- On-Site & Remote Oversight –
• In biotech and pharma: experienced CRAs with deep regulatory knowledge.
• In medtech: Field Clinical Engineers (FCEs) with hands-on technical expertise and full in-house engineering backup. - Risk-Based Monitoring – blending on-site presence with remote oversight to safeguard data quality, patient protection, and site performance.
- Regulatory Compliance – inspection-ready documentation aligned with ICH-GCP, EU MDR, EN ISO 14155, and FDA/EMA requirements.
- Global Reach – senior monitors and FCEs with experience across hospitals, specialised research centres, and clinical research units (CRUs).
We don’t just tick boxes; our CRAs and FCEs act as consultants and problem-solvers, helping sites and sponsors resolve challenges quickly to keep studies on track. With Veron Scientific, you gain clarity, compliance, and confidence at every stage of monitoring.
Quality Assurance
Quality Assurance
We ensure every process, document, and deliverable meets international standards.
Our QA services cover internal systems and vendor oversight, trial master file (TMF) audits, site audits, and inspection readiness reviews. By applying independent quality checks across the trial lifecycle, we help sponsors maintain compliance with ICH-GCP, EU MDR, EN ISO 14155, and FDA regulations, while ensuring data integrity and patient protection.
Medical Writing
Medical Writing
Our expert writers deliver clear, accurate, and regulatory-compliant documents, from protocols and informed consent forms to study reports and scientific publications. Every document is created to support smooth ethics approval, inspection readiness, and effective communication with regulators, investigators, and patients.
Clinical Trial Documents
We prepare and review essential trial documents with clarity and rigour, ensuring compliance with EN ISO 14155, EU MDR, ICH-GCP, MDCG guidance, and local regulations. Our writers work closely with Clinical Operations and Regulatory experts to make sure documents are both scientifically accurate and accessible to ethics committees, regulators, investigators, and patients.
Scientific Publications
We also support the preparation of peer-reviewed manuscripts and scientific articles, presenting study results in a structured, concise, and credible way that stands up to academic and industry standards.
Our Medical Writing Services
- Clinical Investigation Plans (CIP)
- Investigator’s Brochures (IB)
- Patient Information Sheets & Informed Consent Forms (ICF)
- Instructions for Use (IFU)
- Questionnaires & Patient-Facing Materials
- Recruitment Materials
- Clinical Study Reports (CSR)
- Clinical Overviews & Summaries
- Clinical Evaluation Plans & Reports
- Scientific Publications
With Veron Scientific, you gain clear, compliant, and inspection-ready documents that keep your trials on track and your results ready for review and publication.
Vendor Management
Vendor Management
Oversight of all key vendors to ensure seamless coordination and quality delivery.
Clinical trials depend on a network of specialised providers — from central labs and IRT systems to imaging vendors and IMP supply. At Veron Scientific, we take responsibility for selecting, qualifying, and managing vendors, ensuring they meet your study’s technical, regulatory, and operational requirements.
Our Services
- Vendor Selection & Qualification – rigorous assessment of vendors (labs, IRT/RTSM, imaging, IMP manufacturers, couriers, etc.) to ensure quality, compliance, and fit for purpose.
- Contract & Budget Support – negotiation and oversight to secure value and maintain transparency.
- Ongoing Oversight – performance tracking, KPI monitoring, and issue resolution to keep deliverables on time and in scope.
- Compliance Assurance – ensuring vendors adhere to ICH-GCP, EU MDR, EN ISO 14155, and global regulations.
- Single Point of Contact – simplifying communication and accountability for sponsors by coordinating multiple providers through one team.
Clinical Audit
Clinical Audit
Independent clinical audits that secure compliance, data integrity, and inspection readiness.
Staying compliant means more than checking boxes; it means ensuring your data is reliable, your sites are inspection-ready, and your study can withstand scrutiny.
At Veron Scientific, we perform independent audits covering sponsors, CROs, sites, and systems, always aligned with EN ISO 14155 and international regulations. Our services include:
- Internal & CRO audits
- Trial Master File audits
- On-site & inspection readiness audits
With 100+ national and international audits completed, our senior auditors deliver clear reports and practical CAPAs, giving you confidence in compliance, data integrity, and overall study quality.
MedTech
MedTech
Clinical trials in the MedTech industry are often more complex, involving product development, clinical support by specialists in operating theatres or cath labs, and follow-ups. Veron Scientific has decades of experience in medical devices, including pacemakers, stents, valve technologies, neuroprotection, and neuromodulation. Our clinical specialist team provides support in operating theatres or cath labs.
Biotech
Biotech
We support biotech innovators from early feasibility through to pivotal trials, helping accelerate development while safeguarding compliance and data quality. Our tailored CCRC model provides direct access to senior experts and streamlined oversight.
Areas of expertise include:
• Early-phase, first-in-human studies
• Adaptive trial designs and innovative data strategies
• Regulatory submissions and inspection readiness
• Biometrics and data-driven trial management
Pharma
Pharma
We work with pharma companies to design and deliver efficient, inspection-ready trials across global markets. With decades of combined experience, our teams bring regulatory depth, operational excellence, and reliable data insight.
Areas of expertise include:
• Phase I–III clinical development
• Oncology and haematology
• Autoimmune and inflammatory disorders
• Pharmacovigilance and safety management
Let's Connect
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