CoLAB TRIALS
CoLAB TRIALS is a Portuguese non-profit collaborative laboratory that develops digital tools (MD Class, LowRisk@Site, CRF Ready, and the in-development TRIALS READY AI platform) and provides regulatory and clinical study design services to health product developers, medical device companies, biotech firms, and clinical trial units.
- Company typePrivate
- Founded-
- HeadquartersÉvora, Portugal
- Headcount1–10
- GTM typeB2B
- OfferingSoftware
What CoLAB TRIALS does
CoLAB TRIALS (legal name: ASSOCIAÇÃO COLABTRIALS – LABORATÓRIO COLABORATIVO PARA A INOVAÇÃO EM ENSAIOS CLÍNICOS) is a Portuguese private-law non-profit association headquartered in Évora with a secondary office in Lisbon. The organization positions itself as a collaborative laboratory focused on clinical trials innovation, anchored to founding associates Nova Medical School (NMS), University of Évora, Hospital da Luz Learning Health, and the CHRC research unit. Its stated mission is to bring health products closer to clinical trials by addressing pre-clinical and clinical study planning, regulatory strategy for medical devices, biotech products, medicines (including advanced therapy medicinal products), IVDs, and biomarker validation, while increasing the TRL of innovative health products from 4 to 6.
The product portfolio comprises four digital tools built around EU regulatory and clinical operations. MD Class is a public-facing questionnaire tool that determines medical device risk classification under EU MDR (Regulation 2017/745) and outputs a certification roadmap. LowRisk@Site is a clinical trial risk management solution with structured risk categorization, dynamic risk scoring, and automated site-level alerts. CRF Ready is a structured electronic case report form environment for capturing, managing, and validating study data. The TRIALS READY platform (under development from April 2025 to March 2028) integrates these capabilities with AI functionalities for trial design, data analysis, and report generation, alongside an innovation management tool for idea and opportunity management.
Commercially, CoLAB TRIALS combines two revenue streams: (i) expertise and consulting services delivered directly to health product developers, medical device companies, biotech firms, and clinical trial units on a project or contract basis, and (ii) recurring access to digital tools (notably MD Class as a free/professional funnel and subscription-style access to other tools). Pricing is not publicly disclosed and is described as quote-based and engagement-specific. The organization distributes via direct enterprise engagement, EU-funded consortium participation (e.g., TRIALS READY, lead partner DECSIS II Iberia), and ecosystem channels including workshops, industry events (BIOMEET, NOVA Science & Innovation Day, Hospital da Luz Research Congress), and ANI/EIT Health InnoStars networks. Operating geographies are presently limited to Portugal.
CoLAB TRIALS firmographics
Firmographics- Name
- CoLAB TRIALS
- Legal name
- ASSOCIAÇÃO COLABTRIALS – LABORATÓRIO COLABORATIVO PARA A INOVAÇÃO EM ENSAIOS CLÍNICOS
- Website
- https://colabtrials.pt
- Company type
- Private
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- CoLAB TRIALS is a Portuguese non-profit collaborative laboratory that develops digital tools (MD Class, LowRisk@Site, CRF Ready, and the in-development TRIALS READY AI platform) and provides regulatory and clinical study design services to health product developers, medical device companies, biotech firms, and clinical trial units.
- Ownership category
- akta.pro rank
CoLAB TRIALS industry classification
Industry- Product category
- Clinical Trial Software
- NAICS
- Scientific Research and Development Services (5417), Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) (541715)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Clinical CROs (Phase I–IV) (HLAGAAAA)
- akta.pro secondary industry
- Clinical Trial Analytics, Risk-Based Monitoring (RBM) & Quality Management (HLACAOAI)
Keywords
Where CoLAB TRIALS is headquartered
LocationHeadquarters
- HQ city
- Évora
- HQ country
- Portugal
- HQ region
- Europe
Offices2 records
Markets served
CoLAB TRIALS business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure
Revenue model
- Expertise and Consulting Services: Provides regulatory strategy, clinical study design, and implementation services for medicines, medical devices, IVDs, and biomarker validation. Revenue generated through consulting engagements and service contracts.
- Digital Tools and Platforms: Develops and provides access to digital tools including MD Class, LowRisk@Site, and CRF Ready for clinical trial management.
Go-to-market motion2 records
Distribution channels2 records
Marketing channels5 records
CoLAB TRIALS product offering
Product offeringCore offering
CoLAB TRIALS combines expert consulting services in regulatory strategy, pre-clinical and clinical study design, risk management and health-economics evaluation with a portfolio of proprietary digital tools — MD Class (medical device risk classification), LowRisk@Site (risk-based site monitoring), CRF Ready (electronic data capture) and the AI-enabled TRIALS READY clinical trial planning platform — packaged as standalone products and subscription services for medical device and biotech developers bringing innovative health products to market in the EU.
Product overview
CoLAB TRIALS offers a portfolio of specialized digital tools for clinical trials and medical device development. The core offerings include MD Class (a regulatory classification tool for medical devices under EU MDR), LowRisk@Site (clinical trial risk management), and CRF Ready (electronic case report form system for clinical data collection). The TRIALS READY platform represents their integrated clinical trial management solution with AI capabilities. Services span pre-clinical and clinical study design, regulatory strategy for medical devices and biotech products, and IT solutions for clinical trial planning and implementation.
Differentiator
Problem solved
Functional benefit
Brands
- MD Class: Medical device classification tool designed to assist in determining risk classification according to EU regulation 2017/745 (EU MDR).
- LowRisk@Site
- CRF Ready
Products and services
- TRIALS READY AI-enabled clinical trial design and planning platform that helps health product developers structure pre-clinical and clinical study workflows, integrate regulatory strategy, and accelerate readiness for first-in-human studies.
- MD Class Digital medical device risk classification and conformity assessment questionnaire that guides developers through EU MDR classification logic and is accessible free of charge as a self-service tool.
- LowRisk@Site Risk-based monitoring tool that supports clinical trial sites in applying proportionate risk management approaches aligned with regulatory expectations.
- CRF Ready Electronic data capture solution that structures clinical case report form preparation and supports study teams implementing digital data collection workflows.
- Regulatory Strategy Consulting Expert consulting service covering EU MDR classification, conformity assessment strategy, and regulatory pathway planning for medical device and biotechnology developers bringing innovative products to market.
- Clinical Study Design Services Pre-clinical and clinical study design support service that helps health product developers plan, structure and operationalise first-in-human and feasibility studies through to execution.
Companies that use CoLAB TRIALS
Customer profileSegments4 records
Ideal customer profiles2 records
CoLAB TRIALS technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability1 record
Feature4 records
CoLAB TRIALS partnerships and signals
Strategic signalPartnerships
Eleven partnerships are on record, tiered core and minor.
- DECSIS II IberiacoreLead company in the TRIALS READY project consortium. DECSIS II Iberia leads a multidisciplinary consortium including CoLAB TRIALS, University of Évora, and University of Aveiro to develop an innovative integrated clinical trial management platform with AI functionalities.
- University of AveirocorePartner in the TRIALS READY project consortium. Collaborating with DECSIS II Iberia, CoLAB TRIALS, and University of Évora to develop AI-powered clinical trial management solutions.
- University of ÉvoracorePartner in the TRIALS READY project consortium and founding associate of CoLAB TRIALS. Collaborates on clinical trials innovation and hosts the organization's headquarters.
- Nova Medical School (NMS/UNL)coreFounding associate of CoLAB TRIALS. Provides clinical research excellence and hosts CoLAB TRIALS' Lisbon office at CHRC/NMS/UNL. Participates in workshops, consortium projects, and clinical research activities.
- Hospital da Luz Learning HealthcoreFounding associate member contributing clinical research expertise. Co-hosts workshops with CoLAB TRIALS and participates in research congresses and consortium projects.
- CHRC - Comprehensive Health Research CentrecoreFCT research unit that serves as the research foundation for CoLAB TRIALS. Hosts annual summits and provides research infrastructure. CoLAB TRIALS presented at CHRC events including Microcredential programme.
- ULS Lisboa OcidentalminorCollaborates with CoLAB TRIALS on workshop series '...And now?' addressing European projects in health area. Hosted workshop sessions.
- CoLAB AccelBiominorCollaborative laboratory partner. CoLAB TRIALS colleague Fábio Lampreia gave a workshop on regulatory considerations in nonclinical drug development.
- VoH CoLABminorCollaborative laboratory partner. Participated together in round table at Ciência 2024 discussing 'How Can CoLABs Support Global Health Challenges'.
- ANI - Agência Nacional de InovaçãominorNational innovation agency. CoLAB TRIALS participates in ANI-promoted events including EDE-X Spaces for Entrepreneurial Discovery and Capacitation Program for technological infrastructures.
- EIT Health InnoStarsminorEuropean health innovation network. CoLAB TRIALS attended Welcome Networking Cocktail with EIT Health InnoStars Partners at Nova Medical School to establish connections with the InnoStars ecosystem.
Scale indicators2 records
Recent moves6 records
Expansion highlights5 records
CoLAB TRIALS competitors and assessment
Company assessmentBroad incumbents
- Veeva Systems: Veeva's Vault CTMS and Vault EDC are enterprise clinical trial management platforms with AI-augmented capabilities, comparable to CoLAB TRIALS' TRIALS READY platform but serving global enterprise sponsors at significantly larger scale.
- Parexel: Parexel is a global CRO providing clinical trial design, regulatory consulting, and biopharmaceutical services — overlapping with CoLAB TRIALS' advisory and trial implementation scope.
- ICON plc: ICON is a top global CRO offering clinical trial design, regulatory affairs, and post-approval services — a broad incumbent peer to CoLAB TRIALS' clinical study design and regulatory strategy services.
- Charles River Laboratories: Charles River provides preclinical and clinical CRO services, including regulatory and trial management support, comparable to CoLAB TRIALS' clinical research services for medical devices and biotech.
- IQVIA: IQVIA is a global CRO and clinical technology provider whose clinical trial services and analytics platforms overlap with CoLAB TRIALS' study design, regulatory, and AI analytics offerings at much larger scale.
- Medidata (Dassault Systèmes): Medidata's Rave EDC, Rave CTMS, and AI-enabled trial analytics suite compete directly with the data capture, trial management, and analytics modules CoLAB TRIALS is building into TRIALS READY.
Direct peers
- Rimsys: Rimsys is a regulatory information management platform purpose-built for medical devices, directly comparable to CoLAB TRIALS' MD Class tool and broader EU MDR regulatory strategy services.
- Castor: Castor offers an electronic data capture (EDC) and eCRF platform for clinical trials, directly comparable to CoLAB TRIALS' CRF Ready product. Both target trial sponsors seeking structured, compliant data collection workflows.
- Formedix: Formedix provides clinical trial design automation, metadata repositories, and eCRF build tools, closely aligned with CoLAB TRIALS' CRF Ready and TRIALS READY trial design capabilities.
Emerging players
- Greenlight Guru (Rimsys / Datavant): Greenlight Guru provides QMS and regulatory compliance tooling for medical device companies, adjacent to CoLAB TRIALS' MD Class tool and EU MDR regulatory strategy services for medtech innovators.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
CoLAB TRIALS social profiles
Digital presenceCoLAB TRIALS financial estimates
Financial estimateRevenue estimate
Valuation estimate
CoLAB TRIALS leadership team
Management profileNumber of profiles
Profiles1 record
CoLAB TRIALS funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
CoLAB TRIALS M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about CoLAB TRIALS
What does CoLAB TRIALS do?
CoLAB TRIALS combines expert consulting services in regulatory strategy, pre-clinical and clinical study design, risk management and health-economics evaluation with a portfolio of proprietary digital tools — MD Class (medical device risk classification), LowRisk@Site (risk-based site monitoring), CRF Ready (electronic data capture) and the AI-enabled TRIALS READY clinical trial planning platform — packaged as standalone products and subscription services for medical device and biotech developers bringing innovative health products to market in the EU.
Is CoLAB TRIALS a public or private company?
CoLAB TRIALS is a private company. It is classified as nonprofit foundation owned and is currently operating.
When was CoLAB TRIALS founded?
CoLAB TRIALS was founded in -1. It employs 1 to 10 people.
Where is CoLAB TRIALS based?
CoLAB TRIALS is headquartered in Évora, Portugal, in the Europe region.
How does CoLAB TRIALS make money?
Two revenue lines are on record. Expertise and Consulting Services are the primary driver. The others are digital Tools and Platforms.
Who are CoLAB TRIALS's main competitors?
Broad incumbents on record are Veeva Systems, Parexel, ICON plc, Charles River Laboratories, IQVIA and Medidata (Dassault Systèmes). Direct peers are Rimsys, Castor and Formedix. Greenlight Guru (Rimsys / Datavant) is listed as an emerging player.
Does CoLAB TRIALS have an API?
No public API is recorded for CoLAB TRIALS.
What industry is CoLAB TRIALS in?
CoLAB TRIALS's product category is Clinical Trial Software. Its primary akta.pro industry code is HLAGAAAA, Clinical CROs (Phase I–IV), with a secondary code of HLACAOAI, Clinical Trial Analytics, Risk-Based Monitoring (RBM) & Quality Management. Its NAICS code is 5417 and its SIC code is 8731.