Laboratory and clinical study services
EXCO offers a comprehensive range of GxP-compliant services relating to laboratory equipment and technologies. Thanks to our extensive expertise in validation and qualification, as well as our many years of experience with laboratory information management systems (LIMS), we can support you in planning, implementing and optimising your laboratory processes.
We assist study teams in conducting clinical trials by providing structured, compliant data management, including eCRF development and implementation, clinical programming, and clinical trial coordination.
As an experienced service provider to the medtech and pharmaceutical industries, we offer customised, fully documented services that comply with international regulations (e.g. ICH-GCP, MDR, FDA, IVDR).
We also support you in the areas of data management and data analytics.
Our clinical trial services
Our laboratory services
Lab equipment validation and qualification
EXCO offers GxP-compliant laboratory services, including the qualification (IQ/OQ/PQ) of laboratory equipment in accordance with valid GMP specifications and ICHQ. We provide complete documentation to accompany the validation process.
Our services include:
- Qualification planning and implementation (IQ, OQ and PQ)
- Creation of valid documentation (GMP, ICH Q7, AMWHV)
- Risk analysis and change management
- Ensuring compliance with GAMP 5, Annex 11 and 21 CFR Part 11
- Support with audits and inspections by the relevant authorities
- Commissioning and authorization
Process validation
We ensure compliance with regulatory requirements and enable traceable, quality-relevant processes through our standard-compliant, risk-based validation of laboratory processes.
Our services include:
- Analysing and evaluating existing laboratory processes in accordance with GMP/GLP.
- Creation of risk-based validation plans and strategies.
- Implementation and documentation
- Providing support during audits and inspections by authorities.
Method validation
Our validation processes ensure the reliability, reproducibility and suitability of analytical methods, particularly analytical, physical and bioanalytical methods, in accordance with the relevant pharmacopoeia requirements, such as ICH Q, Ph. Eur., USP and GMP.
Our services include:
- Planning and executing method validations (e.g. HPLC, GC, ELISA and PCR).
- Creation and review of validation plans and reports.
- Determining and evaluating method parameters and acceptance criteria (e.g. specificity, linearity, accuracy, precision and robustness).
- Transfer of validated methods to routine laboratories (e.g. device comparisons and operator comparisons) and revalidations.
- Ensuring conformity with GxP, FDA and EMA requirements
CSV validation of laboratory equipment
EXCO offers comprehensive Computer System Validation (CSV) for your laboratory equipment, covering all computerised systems and software components. This ensures reliability and data integrity, as well as compliance with regulatory requirements such as GxP, 21 CFR Part 11 and EU GMP Annex 11.
Our services include CSV of:
- Laboratory Information and Management Systems (LIMS).
- Device software
- Electronic data acquisition systems (e.g. EMPOWER).
- Sample management and workflow control software
- Analysis software and data processing tools
Our clinical trial services
Coordination and Organisation
We support your clinical trials, from preparation to operational implementation, coordinating all parties involved.
Our services include:
- Support with study protocols, submissions and trial site management
- Organisation and monitoring of study conduct in accordance with GCP
- Coordination of all stakeholders and interfaces involved
- Data management, reporting and audit support
Clinical Programming
We take care of the entire process of collecting, processing and analysing clinical study data, from seamless sample tracking and eCRF/EDC data management to SAS programming, statistics and integration with your LIMS.
Our services include:
- Clinical programming (e.g. using SAS, R or Python).
- Data management (eCRF, EDC)
- Data validation and query management
- Biostatistical analyses
- GCP- and CSV-compliant documentation
- Study monitoring and interface coordination
Clinical data management
With our expertise, we support study teams in preparing data in accordance with the FAIR Data principles and international standards (CDISC: CDASH, SDTM, ADaM, LOINC). Electronic Case Report Forms (eCRFs) capture and track key data, providing important insights into the efficacy and safety of the results.
Our services include:
- eCRF design and implementation
- Structured data collection, organisation and analysis
- Interpretation of safety- and efficacy-relevant study data
- Real-time data collection and traceability
Additional services: Data management
Regulatory data management
We offer a comprehensive range of data management services, including all the methods necessary for the statistical evaluation, interpretation and visualisation of your data.
Our services include:
- Statistical evaluation (e.g. trend analysis, variance analysis, regression modelling);
- Visualisation of results (e.g. dashboards, graphics and heat maps).
- Analysis of large amounts of data (e.g. big data, omics, machine learning).
- Support with data pre-processing and cleansing
- Development of customised analysis workflows (e.g. using R, Python or SAS).
- Ensuring compliance with GxP, ICH guidelines and data integrity (ALCOA+)
Data analytics
We use validated statistical and algorithmic methods to consistently link and analyse your data in accordance with regulatory requirements.
Our services include:
- Statistical analysis of laboratory, process and study data
- Structured recording and networking of data
- Creation of smart data concepts
- Creation of meaningful visualisations (e.g. dashboards and heat maps).
- Analysis of large and complex data volumes (big data, omics, AI/ML).
- Data cleansing and pre-processing
- Development of customised analysis workflows (e.g. using R, Python or SAS).
- Ensuring compliance with regulatory requirements (GxP, ICH guidelines, ALCOA+)
