Clinical Trial Support Services

Lab services

For investigators and research teams who need additional support to conduct their clinical trials, CTSI-CN offers an easily accessible suite of services through our Clinical Research Unit team. Investigators at Children’s National can utilize the services of our highly skilled team of research nurses and coordinators, process samples through our laboratory services, and receive consultative support on everything from study design and budget development to study closure. Explore our clinical trial support services and expertise below.

For more information on services or to request support, submit a Research Launcher ticket.


Core Services

CTSI-CN maintains a highly capable and qualified group of Research Coordinators that are available to support research studies at CNH. Coordinator services are flexible and can be purchased to suit the particular demands of a research study. Services provided by our coordinators include:
  • Budget submission
  • Case Report Forms (CRFs) and Electronic Data Capture (EDC) submission
  • Informed consent development
  • Communication support between PI, sponsor, institution, and research participants
  • Study timeline monitoring
  • Regulatory document completion and submission
  • Research participant recruitment and screening
  • Scheduling and management of study visits
  • Study closure
CTSI-CN maintains a skilled group of Research Nurses that are available to support research studies at CNH. Nursing services are flexible and can be purchased to suit the particular demands of a research study. Services provided by our research nurses include:
  • History and physical exam
  • Vital signs and observation
  • Collection of human biological samples (e.g., phlebotomy)
  • Administration of research medication(s)
  • Peripheral line access and maintenance
  • Serial blood sampling (PK/PD Studies)
  • Continuous infusions
  • Oral and IV glucose tolerance testing
  • Cardiac monitoring and 12-lead EKG
  • Documentation of care and reporting adverse events to study team
CTSI-CN offers a range of research laboratory services to help support clinical and translational research at CNH. These services include:
DNA/RNA Extraction

Services include:

  • Batched extraction of DNA using QIAsymphony SP. DNA can be isolated from whole blood, buffy coat, tissue, bacterial and cell cultures, plasma/serum/CSF, and respiratory swab samples
  • Batched extraction of RNA from whole blood and tissue
  • Quantification via NanoDrop Spectrophotometer
Genomics/Proteomics

Services include:

  • Sequencing (whole exome, targeted, microbiome, RNA/miRNA)
  • Illumina and Affymetrix Arrays (profiling, methylation, transcriptome, etc.)
  • Mass Spectrometry (metabolomics, labeled proteomics, post-translational modifications), 2-D Gel
  • Bioinformatics, Statistical Genetic Analysis
  • SNP analysis, ELISA, NanoString, RT-PCR
Sample Processing, Storage, and Shipping

Services include:

  • Simple to complex processing, including refrigerated centrifugation
  • Short- and long-term storage of samples in -80˚C freezers
  • 24-hour temperature monitoring via Isensix
  • Cloud-based sample tracking using FreezerPro Enterprise
  • Ambient and frozen sample shipping by IATA-certified staff

 

Please click here to view the CRU fee schedule.
Coming Soon.

Specialized Services

The CTSI-CN Biorepository provides assistance in the setup, logistics, collection, processing and storage of specimens for biobanking purposes.
Types of Specimens Processed and Stored
  • Whole blood
  • Buccal swabs
  • Urine
  • Saliva
  • Buffy coat
Biobanking Services
  • Specimen collection
  • Specimen processing (e.g.,. DNA extraction) and storage for biospecimens collected in accordance to approved IRB protocols
  • Database management including data entry, sample location, related clinical information, and specimen recovery
  • Coordination of future sample analyses with the Proteomics Genomics Core lab at CNH
  • Prospective biospecimen collection to fulfill investigator needs for IRB-approved protocols
  • Storage for biospecimens collected by investigators under IRB-approved protocols
  • Software tools (Freezer Pro) for sample log, sample data entry, barcoding and location

 

Tab 2 Content
Services include:
Consultation
  • Conduct a preliminary discussion to determine the scope and needs of a specific project
Neuropsychological and Psychosocial Testing Services
  • Performance-based tests for children, adolescents, and adults
  • Questionnaire measures of psychosocial functioning and quality-of-life measures
  • Scoring and interpretation of any neuropsychological or psychosocial measures
Database Construction/Data Capture Tools
  • Use of templates or form development in REDCap for many commonly used measures
  • Patient-completed electronic data capture using a tablet-type device
Trial Development
  • Assistance writing grants with neuropsychological or psychosocial aims or endpoints
  • Development of analytic strategies for neuropsychological or psychosocial measures
  • Help choosing the most appropriate measures and approaches for various neuropsychological- and psychosocial-related research questions
Personnel training
  • Train research personnel to administer or score required measures (given prerequisite qualifications)
  • Assistance ordering research materials that require Psychologist credentialing