Clinical Services
VECTORB2B is a full-service CRO with privileged access to a broad network of clinical sites and recognized KOLs across different therapeutic areas ensuring full flexibility and competitiveness
Clinical Services
A Portuguese organisation along with the expertise of a Global CRO with activity and partnerships across the world.
As a full-service CRO, our solutions include all activities from study design through to study set up, close-out and clinical study report. Services offered include but are not limited to project management, monitoring, data management, statistical analysis and medical writing.
These services cover the entire development life cycle of introducing new therapeutics and medical devices into the market.
Our scientific expertise and experience across different types of therapeutic products, spans from Clinical Trials phases I-IV of investigational products to non-Interventional observational Studies, Real-World evidence projects, and investigational studies for medical devices.
We also provide regulatory support and submission services with a team of regulatory experts, following FDA and European regulations and guidelines.
VectorB2B is your CRO partner in supporting development of your product or device. We develop high-quality flexible solutions for your clinical study program that ensure effective development and fast regulatory approval of your product.
If you are planning to conduct a clinical study, do not hesitate in contacting us!
Clinical Trial Planning and Conduct
Strategic Consulting
• Study planning and development;
• KPIs assessment;
• Contract manager with legal support.
Pharmacovigilance & Risk Management
• Data entry and data safety analysis;
• Report adverse events;
• Risk assessment and management;
• Creating Risk Management Plans (RMPs).
Regulatory Affairs
• Studies submission in Portugal (CEIC, CNPD, INFARMED), Europe and FDA;
• Submission of amendments, progress and safety reports.
Medical Affairs & Medical Writing
• Writing and consulting of clinical study protocolos, informed consent documents, investigator brochures, common technical documents;
• Scientific writing and communications;
• Regulatory medical writing.
Quality Management
• Development of standard operation procedures (SOPs) according to quality standards;
• Monitoring of clinical study procedures;
• Good Clinical Practice Training;
• Support regulatory inspections and audits.
Data Management & Biostatistics
• Database creation and validation; Data management plan;
• Design and hosting of secure eCRF (data cleaning and quality control);
• Management of study closedown;
• Writing, revidewing and support statistical plan; Statistical reports.
Clinical Operations
• Project Management;
• Feasability & Site Selection;
• Site Management & Engagement;
• Study Coordination;
• Patient Recruitment & Retention;
• Regulatory and safety suppot.
Training
• GCP;
• Data Protection Regulation;
• Contract Management;
• CTIS Submission;
• Etc.
Areas of Expertise
• Ophthalmology;
• Oncology;
• Neurosciences;
• Medical Devices;
• Infectious Diseases;
• Food Supplement;
• Cardiology;
• Biological Drugs.
Technology Suite
VectorB2B has a comprehensive suite of technology to collect data and visualize it so that our clients and our own project managers can see status at the study and patient level. Our eSuite includes:
CTMS
Customized dashboard per user role; standard study templates and logs; key performance indicator (KPI) reports; monitoring visit tracking; timeline and milestone tracking; contract management; budget and payment management.
RTSM
Lifecycle coverage for trial supply kit shipment and current status; randomization; allocation and accountability; export of end-of-trial randomization report.
eTMF
Insights through real-time reports; rapid startup timeline; exportable to fully validated eArchive; convenient document management.
EDC
Simple interface; drag and drop configuration; automated data integration and processing; IMP randomization directly within the eCRF
ePRO, eCOA
possibility for patients to directly report data, involving electronic devices such as smartphones, tablets, or web-based platforms; collection and documentation of clinical outcome assessments from patients, physicians or nurses.
eConsent
enables study participants to register for a trial using electronic devices and submit their consent.
