Randomization in clinical trials is the process of ensuring that there is no bias while assigning treatments/therapies to group of patients. At Kreara, the randomization and blinding processes are carried out as per the standard operating procedures. Over the years of experience, it has been observed that traditional randomization approaches may not be suitable in […]
Define.xml is a file required as part of drug submission to FDA. It describes the structure and contents of the data collected during the clinical trial. Over the past 12 years of our experience, we have generated define.xml files for studies pertaining to various therapeutic areas. The main challenge faced during this process has been […]
“Zero Bias- All Random, No Bias” is a web based randomization application developed by Kreara for simple and effective randomization of Clinical Trials. Its flexible design comes with a preloaded list of Stratification variables. During system setup, we can select the required variables from the list. Then the randomization window will be automatically designed with […]
Apple ResearchKit is an open source software framework introduced by Apple that makes it easy for developers and researchers to create apps for medical research. This new framework takes advantage of the sensors and capabilities of iPhone to track movement, take measurements, and record data. Participants can perform activities and generate data wherever they are, […]
Clinical trial study designs can range from open label to blinded. In open label studies, subjects and investigators know which product, each subject is receiving. Whereas, in blinded studies, the subject, investigator, or anyone assessing the outcome is unaware of the treatment assignment(s) to reduce potential for bias. To support standardization of various collection methods […]
To compare proportions between two groups or to test for independence between two categorical variables we use the Chi-square test .But when the categorical data are paired Mcnemar test is the appropriate one. The Basic McNemar test applies to a 2*2 contingency table with the dichotomous variable at time 1 and time 2. If we […]
Do Whitlock Loop Do Whitlock loop is a powerful data step technique, more commonly called DoW loop which has a number of applications. The construction of the Do Whitlock loop is used to SET statement inside a DO UNTIL loop with BY statement to control the loop. The general form of the DoW loop is, […]
The defined variables of the SDTM general observation classes could restrict the ability of sponsors to represent all the data they wish to submit. Collected data that may not entirely fit includes relationships between records within a domain, records in separate domains, and sponsor-defined variables. Related Records (RELREC) is a special-purpose dataset used to describe […]
For SDTM mapping, Protocol and CRF will serve as the initial supporting document, Database schema along with sample data if available will aid in better understanding of the database structure which will give clarity in mapping and defining specification. Annotated CRF (aCRF) will be created against the blank CRF which will map the fields in […]
Logistic regression is used to predict the dependent binary variable using one or more independent variables. In the logit model the log odds of the outcome is modeled as a linear combination of the predictor variables. Logistic regression focuses instead, upon the relative probability (odds) of obtaining a given result category. We get the same […]