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Biosfer Trials

Biosfer Trials provides flexible CRO services for clinical research, combining study coordination, centralized sample management, biostatistics and advanced data analysis. We support scientifically demanding studies through an integrated approach that connects clinical operations, laboratory workflows and data science.

CRO SERVICES: BIOSFER TRIALS

From study start-up to evidence report.

Biosfer Teslab combines more than a decade of scientific and biomedical research experience with growing operational capabilities in clinical studies. Building on its track record in multicentre research, high-throughput sample processing, omics, data analysis and regulated diagnostics, the company is currently involved in clinical research projects with pharmaceutical, nutrition and hospital partners. Biosfer contributes to study coordination, sample and data workflows, advanced statistical analysis, biomarker evaluation, scientific interpretation and reporting. Data analysis has been a central component of Biosfer Teslab projects for many years and remains a core differentiating capability.

Explore capabilities
Multicentre clinical studies Integrated sample operations Data & biostatistics
Integrated execution Clinical + Laboratory + Data
Clinical CoordinationSites, investigators, timelines
Sample OperationsReception, tracking, QC
Data & BiostatisticsAnalysis, modelling, validation
Scientific ReportingInterpretation and dissemination
WHAT BIOSFER TRIALS BRINGS

Integrated CRO delivery across operations, samples and data.

Biosfer Trials is a flexible CRO partner supporting clinical studies across study start-up, site and investigator coordination, regulatory and quality activities, sample operations, data management, biostatistics and final reporting.

01 · CLINICAL

Clinical Operations

Operational coordination across multicentre and investigator-led clinical studies.

  • Study start-up & protocol support
  • Site & investigator coordination
  • Regulatory, ethics & quality support
  • Project and partner coordination
02 · LAB

Central laboratory & sample operations

Centralized infrastructure for traceable, scalable sample workflows.

  • Sample reception & controlled storage
  • Aliquoting & pre-analytics
  • Shipment requirements & tracking
  • High-throughput analytical workflows
03 · DATA

Data & biostatistics

Integrated data-management and biostatistical support across the clinical study lifecycle.

  • Data harmonisation & QC
  • Statistical analysis & modelling
  • Biomarker discovery & prediction
  • Interpretation & reporting
Integrated CRO workflow

One CRO workflow from study start-up to final analysis.

Biosfer coordinates operational, laboratory and data activities within a single CRO framework, helping reduce handoffs between study teams and maintain continuity from execution to analysis.

01Study & protocol
02Sites & investigators
03Samples + clinical data
04Central laboratory
05Data integration & QC
06Biostatistics + AI
07Final reporting
CRO service scope

CRO services tailored to study scope and sponsor needs.

Biosfer Trials can provide an integrated set of CRO-related services covering study preparation, operational coordination, sample and data workflows, scientific analysis and reporting. A particular strength is the ability to connect clinical operations with centralized sample handling and advanced data analysis, avoiding fragmentation between laboratory, biostatistical and scientific teams. The company is particularly suited to investigator-initiated, multicentre and biomarker-intensive studies where close interaction between clinicians, laboratories, data teams and industry partners is essential.

01

Study Start-Up & Protocol Support

Support for study start-up, protocol development and feasibility assessment, including definition of study objectives and endpoints, biomarker strategy, sample requirements and operational workflows.

Study Start-UpFeasibilityProtocol
02

Site & Investigator Coordination

Coordination of participating sites and principal investigators throughout study execution, including site onboarding, study communication, operational follow-up and coordination of study activities and timelines.

Site CoordinationInvestigator ManagementOperational Follow-up
03

Regulatory, Ethics & Quality

Support for ethics and regulatory study requirements, including CEIm documentation, GCP-aligned study processes, SOP implementation, data-protection requirements and quality documentation to support study traceability and audit readiness.

Ethics & RegulatoryGCPQuality & Compliance
04

Central Laboratory & Sample Operations

Centralized management of clinical study samples, including reception, controlled storage, aliquoting, sample tracking, high-throughput processing, analytical quality control and traceable repeat-analysis workflows.

Sample ManagementTraceabilityAnalytical QC
05

Data Management

Study-specific clinical data management, including data-collection design, data intake and integration, data cleaning and harmonisation, quality-control checks, query management and discrepancy resolution.

Data IntegrationData CleaningQuery Management
06

Biostatistics

Statistical analysis planning and execution, including longitudinal, multivariable and survival analyses, derived-variable generation, model validation and scientific interpretation of study results.

Statistical AnalysisModel ValidationScientific Interpretation
07

Advanced Analytics & Data Science

Advanced analysis of clinical and molecular data, including biomarker discovery, predictive modelling, machine-learning approaches, multimodal data integration and advanced visualisation to support study interpretation.

Biomarker DiscoveryPredictive ModellingMachine Learning
08

Clinical Project Management

Study-level project management across clinical, laboratory and data activities, including timeline and milestone tracking, coordination of cross-functional workstreams, risk and issue management, external-provider oversight and deliverable follow-up.

Study OversightMilestones & RisksDeliverables
09

Statistical Reporting & Scientific Writing

Preparation and interpretation of statistical and scientific study outputs, including interim and final analyses, results tables and figures, statistical reports, study deliverables, manuscripts and congress communications.

Statistical ReportingScientific WritingStudy Outputs
Biostatistics & Data Management

Biostatistics integrated from study design to final reporting.

Biosfer Teslab has internal capabilities to design and develop digital tools supporting the management of electronic clinical research data throughout the study lifecycle. These solutions can support structured data collection and import, integration and harmonisation of data from multiple sites and sources, data validation and quality-control workflows, query and discrepancy management, controlled data corrections, dataset versioning, user and permission management, and complete traceability of data changes through audit trails. They can also facilitate the integration of clinical, laboratory and biomarker data and the generation of curated, analysis-ready datasets. This capability enables Biosfer Teslab to develop tailored data-management solutions that strengthen data integrity, consistency, traceability and operational control in multicentre and data-intensive clinical studies.

Data harmonisationAcross centres and data sources
Longitudinal analysisRepeated measures and trajectories
Predictive modellingBiomarkers, ML and validation
Scientific reportingInterpretation, tables and figures
Clinical Data Infrastructure

Traceable clinical data from collection to analysis.

End-to-end connection between sample metadata, analytical outputs and clinical datasets; reproducible data-processing pipelines; structured QC; generation of analysis-ready datasets; version-controlled statistical workflows; results tables and figures; and traceable transfer of final outputs to investigators and study partners.

DATA CAPTURE

Clinical Data Capture

Study-specific eCRF/CRF design and structured data collection, including questionnaires, visit forms, data dictionaries and data-entry specifications.

CONTROL

Data Quality & Integrity

Data validation and quality-control workflows, including query management, discrepancy resolution, controlled data corrections, user permissions, dataset versioning and full audit-trail traceability.

INTEGRATION

Analysis-Ready Datasets

Integration and harmonisation of clinical, laboratory and biomarker data into curated, quality-controlled and traceable datasets ready for statistical analysis.

Why choose Biosfer Trials

A flexible CRO partner for scientifically demanding clinical studies.

Biosfer Teslab is particularly well positioned for investigator-initiated and industry-collaborative studies requiring strong scientific interaction, multicentre coordination, high-volume sample workflows, complex biomarker or omics components, and advanced data analysis. Its main differentiating value is the integration of laboratory operations and data science within the same scientific team: samples can be centrally managed and processed, while the resulting clinical and molecular data are curated, analysed, modelled and interpreted in a coordinated workflow. This makes Biosfer a flexible CRO partner for studies in which scientific depth, analytical capacity and operational execution need to remain closely connected.

Scientific and clinical expertise

Biomedical, translational and analytical expertise integrated into clinical study execution.

Integrated CRO delivery

Clinical operations, sample workflows, laboratory activities and data analysis coordinated within one integrated model.

Biostatistics-led approach

Biostatistics and data science embedded throughout the study lifecycle, not treated as downstream add-ons.

Multicentre coordination

Coordinated management of investigators, participating sites, study partners, samples and data workflows.

Quality & traceability

Regulated-environment experience, SOP-based workflows and traceable, audit-ready study documentation.

Flexible CRO model

Integrated CRO support or selected specialized workstreams tailored to study requirements.

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