Trial services

A one-stop-shop with a full range of services

CHDR is a full-service CRO with over 35 years of experience in clinical research. From study design and conduct to data analysis and final reporting, we offer comprehensive support throughout the entire process. Our team operates in accordance with more than 300 Standard Operating Procedures (SOPs), ensuring consistency, efficiency, and high-quality results at every step. Each team member is trained in Good Clinical Practice (GCP) to maintain the highest ethical and scientific standards. With a strong focus on collaboration and precision, we help bring new treatments to life with confidence and excellence. For more details on the specific services we offer at each study stage—setup, conduct, analysis & reporting, and closeout—please continue reading below.

CHDR operates as a one-stop-shop, providing a full range of services:

Stage 1

Study set up

9 services
CHDR offers a comprehensive setup phase for clinical trials, providing services such as study design, protocol writing, CTA preparation, regulatory submission, volunteer recruitment, pharmacy, data management, statistics and pharmacometrics, (e)TMF, and pharmacovigilance.
- Study design & protocol writing
  
  Tailored, adaptive study designs and protocols with a focus on safety, efficiency, and scientific integrity for optimal clinical trial outcomes.
  
  At CHDR, we specialise in developing flexible, efficient, and scientifically rigorous study designs tailored to meet the specific needs of each client and clinical trial. Our collaborative approach ensures we work closely with clients to create adaptive study designs that can evolve in response to emerging data, optimising study efficiency and outcomes while maintaining high scientific standards and ensuring safety.
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- Regulatory submission
  
  Streamlined regulatory support, from CTA preparation to submission, ensuring fast approval and full compliance with EU regulations
  
  At CHDR, our regulatory department manages the entire regulatory process for your study, including preparing and submitting the Clinical Trial Application (CTA). We provide comprehensive support throughout the submission process, ensuring all required documents are accurately prepared and delivered well in advance of the submission deadline.
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- Recruitment set up
  
  With an innovative, strategic approach, we rise to the challenges of recruiting healthy volunteers and patients for a wide variety of study requirements.
  
  CHDR maintains an extensive, up-to-date database of over 70,000 active study participants, comprising both healthy volunteers and patients. In addition to leveraging this database, our recruitment strategy integrates multiple channels, including our dedicated recruitment website, Proefpersoon.nl, targeted online outreach through social media campaigns and website ads, print advertisements in magazines and newspapers, and patient referral networks. Located strategically in the Netherlands, CHDR is within 30 minutes of the country’s four largest cities, offering access to a diverse and well-connected population. Our study facilities are highly rated by volunteers, with an 8.9/10 satisfaction score, and many participants return for additional studies.
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- Pharmacy set up
  
  Ensuring efficient, high-quality drug preparation and delivery for early-stage clinical research
  
  The GMP-licensed pharmacy at Leiden University Medical Center (LUMC), located in close proximity to our clinical research unit, is our trusted partner in early-stage clinical research. Fully licensed for the import, manufacture, compounding, and dispensation of study drugs, the pharmacy also handles repackaging, labelling, randomisation, and coding of compounds used in our trials.
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- Data management set up
  
  Building robust, reliable data management systems for seamless, compliant clinical trials
  
  A Data Management Plan (DMP) serves as the foundation for every CHDR study. It outlines the data-related requirements and activities, ensuring the blinding, accuracy, integrity, consistency, reliability, and completeness of the collected data. The DMP also includes detailed timelines. Our team and the sponsor’s team work collaboratively to create and implement a DMP that complies with ICH-GCP guidelines. Our study team will also develop a study-specific database by carefully translating the study's schedule of assessments into Promasys, a rigorous system validated through IQ/OQ/PQ in compliance with GAMP 5 and 21 CFR Part 11. This database includes all timepoints for each subject, with integrated validation checks to ensure accuracy. Before the study begins, the database undergoes a thorough review to guarantee the smooth execution of the trial. This meticulous process upholds data integrity and reliability, providing a robust foundation for successful study outcomes.
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- Statistics and pharmacometrics set up
  
  Optimising study design and efficiency through expert pharmacokinetics, pharmacometrics, and statistical support
  
  At CHDR, we incorporate pharmacokinetics and pharmacometrics from the earliest stages of trial planning to optimise study design and enhance resource efficiency. Our expert statistics team provides comprehensive support, including Statistical Analysis Plans (SAP), subject randomisation, and deblinding envelope preparation, alongside detailed power calculations to ensure reliable and statistically significant results. Our dedicated pharmacometrics team offers predictive PK/PD modelling and simulation to support study design and dose selection for (first-in-human) clinical trials, using preclinical or published data of existing compounds where applicable. Additionally, we optimise PK and PD sampling timepoints to minimise patient burden.
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- (e)TMF/ISF
  
  Streamlining study documentation by managing the ISF and supporting seamless TMF integration
  
  At CHDR, we manage the Investigator Site File (ISF) for studies conducted at our facility. Sponsors are responsible for maintaining the Trial Master File (TMF) for their studies. While we do not provide TMF services directly, we are happy to recommend trusted partners who can assist with TMF management. Additionally, we can upload relevant documents from our ISF to the sponsor’s TMF to ensure seamless document integration throughout the study.
- Pharmacokinetic and -dynamic assays
  
  Expert PK/PD bioanalysis to support your clinical trials with precision and reliability
  
  At CHDR, we offer comprehensive pharmacokinetic (PK) and pharmacodynamic (PD) bioanalysis services to support your clinical trials. Our preferred partner laboratory is equipped to develop and validate PK analysis methods tailored to your investigational drug, ensuring accurate and reliable measurement of drug concentrations in biological samples. Additionally, we can establish PD assays to assess the biological effects of your compound, providing valuable insights into its mechanism of action and therapeutic potential. By leveraging our expertise and state-of-the-art facilities, we ensure that your bioanalytical needs are met with the highest standards of quality and precision.
- Biomarker Engineering and Analytics
  
  Engineering precision biomarkers to advance safer, smarter drug development
  
  Biomarkers are crucial for understanding the efficacy and safety of novel drugs in clinical trials. The Biomarker Engineering and Analytics (BEA) group is engaged primarily in the development of new measurement methods that generate biomarkers to quantify drug effects in human volunteers. Our group brings together research professionals with a range of expertise: electrical and biomedical engineering, technical medicine, data science, (cognitive) neuroscience, and validation processes.
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Stage 2

Study conduct

8 services
We conduct studies in our state-of-the-art, purpose-built facility, equipped with advanced technology and supported by a team of dedicated professionals, ensuring high-quality execution and a seamless study experience.
- Healthy volunteer & patient recruitment
  
  Efficient, targeted recruitment strategies to connect the right participants with the right studies
  
  At CHDR, once the Medical Ethics Committee approves a new protocol, we promptly post study details on our dedicated recruitment website (proefpersoon.nl) and reach out to potential volunteers from our extensive database through phone and email. To meet enrollment targets, we also use targeted advertisements when necessary.
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- Clinical research unit
  
  Optimising early phase clinical trials with state-of-the-art facilities
  
  Based in the heart of the Bioscience Park in Leiden, The Netherlands, we offer state-of-the-art facilities for early phase clinical trials. Our main, purpose-built Phase 1 unit features 54 beds, designed to optimise the clinical trial process, including modern volunteer accommodation, dedicated research rooms, and efficient sample management. Additionally, we have 8 beds at the nearby LUMC for higher-risk compounds or studies that require advanced imaging or specialised patient care.
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- Clinical execution
  
  Precision-driven clinical trials with expert teams and cutting-edge facilities
  
  At CHDR, we conduct clinical trials with the utmost attention to detail and quality, ensuring each study is managed with precision and expertise, and always in accordance with our established standard operating procedures (SOPs). Our purpose-built facility in Leiden is designed to streamline the clinical trial process, supporting everything from First-in-Man studies to advanced pharmacology research.
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- Pharmacy services
  
  Seamless study drug management in partnership with LUMC’s GMP pharmacy
  
  At CHDR, we work closely with the adjacent GMP pharmacy at Leiden University Medical Centre (LUMC). Together, we ensure the seamless management of study drugs, from receipt and storage to the preparation and release of medication, all in accordance with the sponsor’s instructions. Our pharmacy services include assisting in the creation of pharmacy manuals, organising randomisation, preparing the study drug for administration, and managing dispensing. The medication is prepared at the LUMC pharmacy and delivered to our clinical research unit by our dedicated logistics officers, ensuring it is stored under the correct conditions throughout the study.
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- Data management services
  
  Ensuring data accuracy, security, and compliance with advanced management systems
  
  At CHDR, we prioritise the accuracy, integrity, and security of data throughout the study process, ensuring that all data is complete, correct, and properly documented. We use Promasys®, a validated protocol and clinical data management system, to efficiently collect and manage data. Promasys® maintains an audit trail of all data actions and enables prevention of unauthorised access and data protection through secure backup systems. User acceptance testing (UAT) is conducted to verify that databases fully meet the protocol requirements.
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- Statistics and pharmacometrics services
  
  Ensuring safety and accuracy with blinded interim analyses throughout your study
  
  At CHDR, we conduct interim analyses during studies to assess the safety and progression of treatment cohorts before database lock. These analyses help determine whether it is safe to increase the dose for the next cohort and provide accurate power estimations for the study. Interim analyses are always described in the protocol and, when applicable, in the statistical analysis plan (SAP).
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- Bioanalysis
  
  Comprehensive bioanalysis and sample management for high-quality clinical research
  
  At CHDR, we offer comprehensive bioanalysis services to support clinical trials. Our sample management lab is fully equipped to process, store, and ship study samples to our subcontracted laboratories for clinical chemistry and haematology (Leiden University Medical Center), as well as advanced bioanalysis techniques such as mass spectrometry, immunochemistry, flow cytometry, and qPCR at our preferred laboratory, or any other laboratory preferred by the sponsor. We also operate a state-of-the-art in-house cellular lab, equipped with advanced equipment including flow cytometers, multiple flow hoods and incubators, a fluorescence microscope, a stereo microscope, and ELISA and ELISPOT readers. In this dedicated lab, we handle fresh samples collected directly from study participants. For analyses that require immediate testing on fresh samples, we perform bed-side assays in our lab, allowing for rapid, real-time results. For all other analyses that do not require fresh samples, we collaborate with external laboratories to ensure the highest standards of bioanalytical services.
- Regulatory support
  
  Ensuring regulatory compliance and study integrity with expert clinical trial assistants
  
  Our Clinical Trial Assistants (CTAs) play a crucial role in ensuring regulatory compliance throughout the study execution process. They manage trials in the Clinical Trials Information System (CTIS), handling key tasks related to the study's life cycle. This includes notifying relevant authorities of study milestones, preparing and submitting amendments when applicable, reporting serious breaches, unexpected events, and safety measures, and submitting annual safety reports in a timely manner. Their support ensures that each trial adheres to regulatory guidelines, maintaining the integrity and compliance of the entire study.
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Stage 3

Analysis & Reporting

5 services
Our reporting and analysis services involve rigorous data review and statistical analysis, ensuring accurate interpretation of study results, and delivering clear, comprehensive reports that support informed decision-making.
- Biomarker Engineering and Analytics
  
  Engineering precision biomarkers to advance safer, smarter drug development
  
  Biomarkers are crucial for understanding the efficacy and safety of novel drugs in clinical trials. The Biomarker Engineering and Analytics (BEA) group is engaged primarily in the development of new measurement methods that generate biomarkers to quantify drug effects in human volunteers. Our group brings together research professionals with a range of expertise: electrical and biomedical engineering, technical medicine, data science, (cognitive) neuroscience, and validation processes.
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- Data preparation
  
  Delivering complete, accurate data for confident clinical decisions
  
  Once the clinical phase of a study is complete, our Data Management department ensures that all data is accurate and ready for analysis. At the time of study closure, we perform a database lock (DBL), which is carefully planned in alignment with the study timeline. This process involves ensuring that all relevant data has been entered, reviewed, and approved, with no missing or unresolved issues. We also conduct thorough data checks to verify quality and accuracy. If applicable, a statistician will generate a blind data report to assess pharmacodynamic variables, ensuring that any outlying data is handled without bias. Through these steps, we ensure that the study data is complete, accurate, and ready for the next phase of analysis.
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- Data analysis
  
  Expert statistical analysis for transparent, protocol-driven results
  
  At CHDR, we offer expert statistical analysis to ensure the accuracy and integrity of your clinical study data. If a Statistical Analysis Plan (SAP) is provided, analysis proceeds according to the plan; otherwise, it follows the study protocol, with any deviations documented in the statistical and clinical study reports. Data is exported from Promasys into a raw ASCII file (.txt or .CSV), accompanied by a SAS script that converts the data into a SAS-compatible format. The data is then cleaned and refined, addressing any inconsistencies found during the blind data review. We apply a standard statistical approach using SAS scripts, tailored as needed for each study. The final results are presented in a comprehensive statistical report, including listings, plots, tables, and figures, all aligned with the protocol or SAP specifications.
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- CDISC
  
  Standardising data for quality, compliance, and efficiency in clinical trials
  
  At CHDR, we use a standardised in-house approach to structure and report clinical trial data, ensuring consistency and quality in early-phase research. While our internal format is optimised for efficient analysis, we can transfer data to the CDISC standard when needed. CDISC is a globally recognized framework that standardizes clinical trial data for regulatory submissions, with agencies like the FDA and EMA requiring formats such as SDTM for raw data and ADaM for analysis-ready datasets. Our in-house statistics department manages SDTM conversion, while we often collaborate with our expert partner for ADaM, ensuring compliance with industry standards while maintaining our efficient data processing methods.
- CSR writing
  
  Ensuring compliance, clarity, and quality in every clinical study report
  
  At CHDR, we ensure that every clinical study is reported with the highest quality and regulatory compliance. Our CSR template guarantees clear, structured, and regulatory-ready reports, tailored for clinical pharmacology studies. We combine flexibility with adherence to Annex I, Part I, Module 5 of Directive 2001/83/EC1 and ICH-GCP Guideline E3, streamlining the reporting process while maintaining scientific integrity. All our CSRs are peer-reviewed by an external medical writer and QC-checked to guarantee the quality of the report. A lay summary in both Dutch and English and a summary of the results will be written and submitted in CTIS with sponsors' approval to adhere to regulatory requirements.
Stage 4

Study close out

2 services
Our study close out services ensure the finalisation of all clinical activities, including data reconciliation, regulatory documentation, and the preparation of comprehensive study reports, ensuring compliance and a smooth transition to the next phase.
- Regulatory close out
  
  CHDR offers comprehensive regulatory support by providing annual progress reports to the EC, ensuring compliance with mandatory reporting requirements for ongoing research. Additionally, CHDR facilitates the submission of the clinical trial report (M3) and/or any relevant scientific publications within one year of the global study completion as per regulatory requirements.
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- Archiving
  
  Paper study files are temporarily stored at CHDR in fireproof cabinets during the study. Authorised staff ensure that all documents are complete and final before archiving. After the study is finished, study documents are transferred to a nearby storage facility with appropriate environmental controls and adequate protection from fire, flood, and unauthorised access for a minimum of 25 years. Electronic clinical data is stored into our database Promasys for at least 25 years. After the retention period, actions will be taken to anonymise the data as per GDPR requirements.

Advancing the boundaries of clinical drug development

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Trial Services

A one-stop-shop with a full range of services

CHDR operates as a one-stop-shop, providing a full range of services:

Study design & protocol writing

Regulatory submission

Recruitment set up

Pharmacy set up

Data management set up

Statistics and pharmacometrics set up

(e)TMF/ISF

Pharmacokinetic and -dynamic assays

Biomarker Engineering and Analytics

Healthy volunteer & patient recruitment

Clinical research unit

Clinical execution

Pharmacy services

Data management services

Statistics and pharmacometrics services

Bioanalysis

Regulatory support

Biomarker Engineering and Analytics

Data preparation

Data analysis

CDISC

CSR writing

Regulatory close out

Archiving

Advancing the boundaries of clinical drug development