Are you planning clinical or RWE studies in Europe?
Our team of professionals brings over 15 years of extensive expertise in clinical research. We help you navigate the complex landscape of clinical and socio-economic studies and their regulatory requirements. Our goal is to ensure your asset is not only groundbreaking but also scientifically validated and compliant with industry standards. We facilitate the planning and execution of studies to ensure optimal compliance and effectiveness.
Do you plan to outsource your study (in full or partially)?
Choosing to outsource your study can be a significant decision, and selecting the right vendors is crucial to its success. We specialize in matching your specific study needs with the perfect vendors to ensure optimal outcomes.
Do you wish to implement a decentralized study approach?
Our innovative approaches and strategic insights enable us to map decentralized study possibilities, offering flexibility and improved patient engagement.
Are you looking for a consultant in clinical research to join your team?
Our experts are available to join your company temporarily to support your in-house team. Whether you need strategic advise, short-term expertise to navigate complex challenges or additional resources to handle increased workload, our consultants bring valuable insights and hands-on experience to ensure the success of your clinical projects.
Our services
Review of Study Design and Study Related Documents
- Review of study design
- Feasibility assessment to ensure practical and efficient study execution
Regulatory Strategy Guidance
- Expert guidance on regulatory pathways and requirements
- Review of regulatory documents to be submitted to authorities such as EMA, and other relevant bodies.
- Continuous support throughout the regulatory approval process
Project Management and Study Oversight
- Comprehensive project management from initiation to completion
- Quality control and risk management to maintain study integrity and compliance
Site Selection and Qualification
- Selection and qualification of sites and investigators
Training and Education
- Educational workshops on the latest trends and developments in digital health clinical research.
- Ongoing mentorship to build internal capabilities
Vendor Selection and Management
- Comprehensive assessment of potential vendors, including CROs and technology providers.
- Creation of detailed RFPs that clearly outline your project requirements and expectations.
- Vendor contract negotiation
- Continuous monitoring of vendor performance against agreed-upon benchmarks and KPIs.
- Facilitation of effective communication channels between your team and the vendor
Our experience
With and within pharmaceutical companies and contract research organizations
We worked within both large pharmaceutical companies and Contract Research Organisations (CROs):
- Johnson & Johnson
- Novartis
- AstraZeneca
- Pivotal Clinical
Therapeutic areas of expertise
Our team has successfully navigated the complexities of numerous therapeutic fields, including
- Oncology
- Neuroscience
- Cardiology
- Rare Diseases
- Ophthalmology
- Gastroenterology
- Pulmonology
Versatile experience with various vendors
Our comprehensive experience extends to collaboration with a diverse range of vendor types, enhancing our ability to provide tailored and efficient solutions.
Full Service CROs: We partner with full-service CROs to offer end-to-end study management.
Specialty Vendors: Our network includes specialized vendors for biostatistics, auditing, legal services, regulatory affairs, health economics, and medical call centers.
Digital Technology Providers: We leverage advanced digital technologies, including eCOA/ePRO, EDC, eTMF, eISF, eQMS, and wearables, to streamline clinical trial processes and improve data accuracy and accessibility.
