Below you can find answers to the most frequently asked questions that we get about our SEND services.
List of Study Types we support, but not limited to:
- General Toxicology
- Embryo Fetal Development
- Fertility & Early Embryonic Development
- Pre/Post Natal Development
- Juvenile Studies
- Safety Pharm/ CNS Pharmacology
- Distribution or Impurities Studies
- Local Tolerance Study
- Immunogenicity or Immunotoxicity Studies (Cytokines, FACS, IHC)
- Tumorigenicity and Omics (gene, protein, transcriptomics) Studies
- Pharmacodynamic Drug Interactions and ADA
- Respiratory Pharmacology
- Cardiovascular Pharmacology
- Efficacy-Xenograft Studies
- Animal Rule Counter-Measures or Efficacy Studies
The types of studies supported are not limited to the above list. Reach out to us at email@example.com to know more about other innovative pre-clinical studies.
We support all types of digital formats such as LIMS extracts including xmls, csv, xpts, xls etc. We also support study reports in PDF format if the LIMS outputs are not available, including scanned PDFs (handwritten).
Turnaround times are dependent on the type, nature and complexity of the study. Our typical turnaround time for a short to medium term general tox study is 3-4 weeks depending on the volume of studies being standardized at that point of time. For larger studies such as Carc or Reprotox,, this may average about 4-5 weeks.
We also provide expedited services where we can cut the turnaround time down by half provided that the Sponsor/ CRO gives us a lead time of about a month.
Yes, we do a 100% Quality Check (QC) on all SEND datasets that we generate through our SEND ASSURE QC services. It includes a thorough check of CRO and 3rd Party generated SEND datasets against the final PDF Study Report’s metadata and its tabulated data, validation against all applicable conformance rules of CDISC, FDA, PMDA with eDataValidator;and SEND IG best practices.
Digital Study Report (DSR) is a digitized extract of the PDF Study Report for use by 3rd Party SEND preparers or CROs; as for QC checks of separately prepared SEND datasets. The DSR service delivers a digital study report tabulated for machine readability, and contains all the required study metadata and summary tables in the study report, and a complete set of Trial Design domains informed by the actual study design used in the study according to the Study Report. DSR carries the digital extracts of the Study
Director’s conclusions. DSR can be used to QC the SEND dataset by regenerating the summaries published in the Study Report for the same cohorts and groups.
Interim Study Monitoring involves the ingestion of on-going study data generated by your CRO and internal / external labs on a periodic basis into our Xbiom™ platform for Search, Visualization and Analysis. Xbiom interacts directly with the LIMS system to pull the interim data to harmonize and normalize into a Universal Data Model, thus making data coming from disparate sources longitudinally analyzable. Data that is brought into Xbiom can easily be converted into a desirable target format (like SEND, SDTM) once the study is finalized. This allows sponsors to make data driven decisions upfront even as the study is on-going rather than towards the end of the study.
UDM is the Universal Data Model for the Xbiom repository and data warehouse. UDM holds data from assays, studies (in-vivo clinical or animal studies), and other data with their relationships intact and with fidelity. UDM allows for multiple layers of derived, extracted, modelled metadata as well as collaborative and examined generated metadata to form a data services layer that can make it accessible by APIs. UDM is designed with FAIR principles.