Regulatory / Ethical Submission
Comprehensive support throughout the regulatory and ethical submission process, ensuring compliance with national and international requirements.
Services include:
- Support in the elaboration and adaptation of study protocols.
- Preparation and adaptation of the patient information sheet and informed consent form.
- Compilation of local documentation for the submission dossier.
- Support in the negotiation and management of site contract agreements.
“Ensure Compliance. Accelerate Approval.”
Clinical Trial Registry
Design and registry of study protocols in ClinicalTrials.gov
“Register Protocols. Build Transparency.”
Electronic Case Report Form (eCRF)
Design and management of electronic data collection systems, including OpenClinica, REDCap and LimeSurvey.
“Digitize Data. Streamline Research.”
Monitoring Activities
Full monitoring services ensuring quality, traceability, and compliance of clinical trials.
Services include:
- Preparation of the Investigator’s Site File (ISF).
- Planning, conduct, and reporting of initiation visits, regular monitoring visits, and close-out visits.
- Review of monitoring reports and continuous study follow-up.
- Support in the database lock process.
“Monitor Integrity. Secure Outcomes.”
Pharmacovigilance in Clinical Trials
We provide comprehensive pharmacovigilance support to ensure the highest standards of safety monitoring in clinical research. With the oversight of an EU Qualified Person for Pharmacovigilance (QPPV), our team is dedicated to the early detection, assessment, and prevention of adverse reactions, while guaranteeing compliance with all regulatory obligations.
Key Services:
- Training pharmacovigilance programmes for investigation teams.
- Management and reporting of SAEs/SUSARs.
- SAE reconciliation activities.
- Systematic literature search and review.
- Preparation and submission of safety reports.
“Detect Risks. Protect Patients.”
Translation and Editing Services in Clinical Research
“Communicate Clearly. Ensure Compliance”
Clear and precise communication is critical for scientific rigor in clinical research and a key component of regulatory compliance and patient safety. It is crucial that all documentation, ranging from complex technical study protocols to patient-facing materials, is precise and culturally appropriate.
Our translation and editing services are designed to meet these critical demands, ensuring that your research adheres to the highest standards. These services are available in:
- English (UK or USA only).
- Portuguese (Portugal).
- Spanish (Spain).
- Other variants of Portuguese (e.g., Brazil) and Spanish (e.g., variants from Latin America) upon assessment of the requested service
Average services delivery time limits:
- Standard (500-800 words/day)
- Express (1000-1500 words/day)
- Urgent (only for documents with up to 2000 words)
Statistical Services
Our team combines expertise and precision to provide statistical solutions tailored to the specific needs of each research project. Every study is unique, and we work to turn data into solid, evidence-based decisions.
Key Services:
- Support in defining the research protocol.
- Guidance on selecting data collection technologies.
- Sample size calculation.
- Development of the Statistical Analysis Plan.
- Execution of statistical analyses with detailed technical reporting.
- Validation and consultancy on conducted data analyses.
- Methodological review and support in drafting abstracts and scientific articles.
“Decode the Data. Strengthen Decisions.”
Intellectual Property Protection
Intellectual property (IP) is intangible property and can be viewed as the results and outcomes of research. Its commercial value may be realized via various routes including licensing or selling intellectual property rights (IPR). IPRs may be found in Inventions, Software, Materials, Databases, Processes, Research Tools and Creative Works.
Thus, it is important to contact us before sharing your innovation, in order to discuss its full potential and our process, which may lead to requesting protection for your innovation with patents, copyrights, trademarks, or know-how, as applicable, based on its commercial potential.
Our team is in place to offer expertise and guidance for all stages of the process, starting with the discovery, submission of IP disclosure, internal evaluation, IP protection and management, up until the phase of technology transfer.
This support includes:
- Establishing a strategy for the efficient management of intellectual assets.
- Clarifying ownership of intellectual assets in joint research.
- Bridging the gap from intellectual assets creation to the market.
“Safeguard Innovation. Unlock Potential.”
