Frequently Asked Questions

How do I get in contact with Cronos CCS?

You can contact us by phone at (201) 299-2244 or toll free at (877) 673-7079, or by email at help@cronosccs.com

Why is Cronos Data Monitoring so important to my study?

The Cronos Data Monitoring System is a software developed and patented by Cronos CCS that allows sponsors to monitor the quality of symptom assessment data throughout the duration of the Clinical Trial.  Rather than analyzing data at the completion of a failed trial, our system monitors data in real time.  This provides the opportunity to identify and address assessment problems immediately so that the trial can continue successfully.

Who are the Clinical Specialists?

The Clinical Specialists employed by Cronos have many years of clinical experience with patients, efficacy scales, and drug development. Clinical Specialists are selected based on their education, experience, and interpersonal skills. We also use world-recognized experts as consultants; many of whom are the primary authors of the scales used in psychiatry trials.

In what countries has Cronos provided data monitoring services?

Cronos has worked in over 50 countries including: Australia, Agrentina, Bulgaria, Belgium, Canada, China, Croatia, Columbia, Czech Republic, Estonia, Finland, France, Germany, Hungary, India, Italy, Japan, Malaysia, Mexico, New Zealand, Norway, Philippines, Poland, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Ukraine, U.S.A, U.K.

Is the Cronos system 21CFR Part 11 compliant?

Yes, the Cronos system is documented in accordance with 21CFR Part 11 guidelines and we have passed multiple third-party system audits.

What type of problems can Cronos data monitoring detect, correct and prevent?

Inconsistencies and discrepancies detected by Cronos’ algorithms are indicators of risk and possible serious study issues such as inappropriate patient selection, protocol deviations, improperly performed patient interviews, or improper study conduct.  Our evaluation and real-time corrective actions ensure that:

  • Aberrant and idiosyncratic conceptualization of scale items are corrected
  • Naïve raters are guided in the correct usage of the instruments
  • Cultural misconceptions of scale items are remediated
  • Scale anchors are appropriately applied in real-world patient interviews
  • Scoring problems are identified and corrected before the next patient interview
  • Procedural errors are identified and corrected before they become problematic

Can Cronos help us with patient selection and enrollment?

Yes.   Enrollment bias and baseline score inflation are additional risk factors influencing trial outcome.  Enrolling the appropriate study participants and correctly setting baseline levels of symptom severity is critical to a successful trial.

Our solution allows you to:

  • Monitor site administered screening and symptom-severity assessments
  • Objectively determine enrollment
  • Correct Axis IV concerns
  • Account for known country based quality issues
  • Calibrate the site raters to a Cronos expert trainer cohort for subsequent interviews

Can Cronos help us confirm site feasibility?

Yes, data from Cronos’ ongoing monitoring relationships with sites can help to produce accurate, objective feasibility projections. Understanding the characteristics that make a site suited to one type of study versus another forms the basis of comprehensive investigator profile which will guide the Sponsor in current and future site selection efforts.  Cronos enhances the Sponsor’s site feasibility process by utilizing our Site Performance Database to verify a site’s capability to:

  • Meet enrollment targets
  • Produce high data quality
  • Comply with protocol requirements
  • Adhere to accepted standards of clinical research
  • Recruit appropriate patients in an acceptable timeline

What indications/instruments does Cronos support?

Cronos has participated in many indications and we have an extensive list of instruments. As a result of sponsor demand, we are always adding new instruments to our portfolio.

Schizophrenia - PANSS, NSA-16, BPRS, SAPS, SANS, CDSS
Depression - MADRS, HAMD, IDS, CDRS
Alzheimer’s Disease - ADAS-Cog, NPI, MMSE, NTB, CDR, CGIC, DAD
Autism - IVIR, ABC, ADI-R, ADOS
Bi-Polar - YMRS
Anxiety - HAMA, GAD
ADHD - Connors
Global - CGI-I, CGI-S, GAF, PSP
Parkinson’s - UPDRS, SAS
Tourette’s - YGTSS