Cytespace has entered into agreements with a large number of sites across the regions we operate in. These sites are prepared with basic physical infrastructure, well-functioning ethics processes and experienced investigators and site staff.
Cytespace agreement makes the separation of responsibilities between the institution, the investigator and Cytespace very clear, and this forms the basis of the collaboration. The fundamental principle is that the effort required to conduct a clinical trial is a combination of patient care and administration/conduct of the trial at the site. While all aspects of patient care are fully in the domain of the investigator, the activities other than patient care are outsourced to Cytespace and the delegation log for every study articulates this.This helps the investigator focus their time on patient care while being comfortable that the remaining parts of the trial are being managed by qualiﬁed and trained staff at the site.
It is also of solace to the investigator and the institution that they are not burdened with the day-to-day aspects of managing staff who have a career aspiration to do more in clinical research since Cytespace can uniquely provide them this opportunity.
Cytespace has developed multiple models of engagement with hospitals and investigators. Some of these models allow Cytespace to manage just a few of the studies at the site, whereas at some other sites all of the studies and all prospective studies are managed by Cytespace. This engagement model is built to suit the requirements of each hospital and investigator.
Management of clinical trials is a specialized function, and in these days of increased risk and highly complicated trials, the management should be outsourced to a specialist like Cytespace. We are happy to work with hospitals and investigators who are interested in conducting research.
Build metrics around variability between how much was promised during feasibility and actually delivered; how many data queries per patient per study, and how are these trends measured; how many monitoring follow-up action items were sent to the site, how many were unresolved after 15 days, 30 days, 3 months; has a regular QA been done of the studies that are currently done by your institution and how many unresolved issues persist beyond 15 days. 30 days, 3 months
Develop the vision (Why does your institution do clinical trials) and a governance model to establish and monitor your goals for clinical research processes to make sure that the key decision makers and key investigators are involved in the governance process, and establish frequency for their meetings and ac avtive process in the institutions to meet the goals.
Processes and metrics to measure through-put in clinical trials; number of studies, or number of patients per study who have benfitted from trials; metrics to show how much you are currently doing, what you have done in the past; processes and metricsyou have put in place to meet your targets for the future.
Cytespace offers Clinical Research Solutions for studies across all the phases of clinical trials, which not only translates into Phase I – IV but also Studies which includes Non-inferiority and Bioequivalence to name a few. We offer end to end solutions for all phases of clinical trial which is backed by a highly talented team with a wealth of experience.
Cytespace offers its wide array of expertise in site solutions and biometric solutions across therapeutic areas including but not limited to Oncology, Neurology, Psychiatry, Infectious disease, Pulmonary Diseases, Immunology, Vaccines, Cardiovascular, Metabolism, Medical Device Related, Endocrine and Metabolism, Rare Diseases, Respiratory, Dermatology, Genetic Disorder, Nephrology and Ophthalmology.
Cytespace focuses on providing customizable solutions to clients and CROs to meet their requirements. The team provides End-to-End services, including Data Management, Medical Coding, Programming & Validation, Records Management, Study Start-up, Biostatistics and Statistical programming.