Contract Research

Kreara places a keen focus on the clinical contract research industry and has been one of our major areas of expertise all through our existence. The CRO industry developed mostly in the late 1990s when pharmaceutical R&D efforts became more complex and competition in rapidly-growing therapeutic areas increased. As industry margins came under increasing pressure, companies began outsourcing aspects of their development, manufacturing or marketing processes so as to concentrate on their core specialties.

Outsourcing has been particularly influential in the pharmaceutical industry as the success of a large pharmaceutical company depends on competence in fields as diverse as combinatorial chemistry, computer integrated manufacturing and marketing medicines directly to consumers.

External cost pressures have acted as a major driver for the pharmaceutical outsourcing market. At bottom, the outsourcing market has developed in response to the downward and upward cost pressures exerted on pharmaceutical manufacturers’ profit margins. Given that such pressures are likely to increase in the future, CROs will become more and more important strategic partners for pharmaceutical companies

Clinical Data Management

Kreara provides a complete continuum of data management solutions to pharmaceutical, biotechnology and medical device industries worldwide. The data management group at Kreara develops a comprehensive data management plan detailing the requirements and actions, based on client input. The data management team undergoes brain storming discussions within the team and with the client to clarify the project requirements.

The data management team at Kreara reflects a blend of internal efficiency, flexibility and experience resulting in a customized service that demonstrates commitment to meeting the timelines and project goals set by the clients. Further, Kreara data management group works to meet high-level global standards.

A set of standard SOPs related to data management ensure that the data management tasks are performed in a consistent manner throughout the company.

Services provided by Kreara under the Clinical Data Management include:

• Preparation of the Data Management Plan
• Development and set up of the e-Randomization application
• Acting as the randomization center
• Maintenance of the blind for the study
• CRF design and development
• Preparation and set up of the e-CRF application
• Preparation of the Data Definition Table
• Design and set up of the Database tailored to CRF specification
• CRF scanning and Data Entry using a Data Entry application with built in validation checks
• Data Verification using single or double data entry methods
• Data Validation
• Execution of the Blind Review
• Handling of external data like laboratory ranges and pharmacokinetic data
• MedDRA coding for Adverse Events
• Coding for Concomitant Medication
• Serious Adverse Event Reconciliation against client safety databases
• Raw Data Listings and tables available in formats including Excel and SAS®
• Data Exports into several formats, including SAS®, SPSS and Oracle®
• Migration of data into CDISC standards

Bio Statistics

Biostatistics or biometrics is the application of statistics to health related studies. Biostatistics finds its application in the fields of medicine, biological and clinical studies. This science includes the design of studies, collection, summarization, analysis and interpretation of data and also the inference from results.

The services provided by Kreara in this area are

• Sample size determination
• Providing input to the statistical section of the study protocol
• Preparation of the Statistical Analysis Plan based on the study protocol
• Designing the tables and listing templates
• Spearheading the analysis of the data
• Interpretation of the results obtained from the analysis
• Preparation of the integrated final report

Kreara has a team of well qualified statisticians with a combined experience of more than 10 years in providing biometrical services to clinical trials pertaining to various therapeutic areas. The team is encouraged to take active part in internal and external training sessions and conferences to remain updated with the latest trends in statistics. The team structure of statisticians includes a Project Statistician who leads a team of statisticians to accomplish the timelines effectively and efficiently. Brain storming sessions are held on a periodic basis to ensure that the statistical methodologies applied for the particular study are apt and effective.

Regular status meetings within the team and with the client are held to discuss issues and also to keep track of the project progress.

Medical Coding

Medical coding refers to the standardization of free text data recorded as part of Adverse Event, Concomitant Medication and Medical History collection. Medical coders resort to standard dictionaries for this purpose.

At Kreara, the MedDRA dictionary is used for coding Adverse Events and Medical History data while the WHO-DD dictionary is used for coding Concomitant Medications. Kreara has an expert team of medical coders with vast experience in coding of adverse events, medical history and concomitant medication for studies in various therapeutic areas. It is ensured that the versions of the dictionaries are upgraded as per the availability of the latest versions.

The team forms part of discussion forums and thereby keeps track of latest developments in this area. Kreara ensures that the medical coding is performed as per standards in an effective and timely manner.

SAS Programming

SAS software provides a complete, comprehensive set of tools that can meet the data analysis needs of the entire organization. The data management, analysis and reporting capabilities are utilized in Kreara for all the clinical and statistical projects. Kreara at present works in SAS 8.2 and plans to migrate to the later versions in the near future.

Kreara has a skilled team of certified programmers with extensive exposure and experience in various modules of SAS. The blend of statisticians and SAS programmers in the team ensures effective and competent use of SAS for statistical analysis of data. The expertise of the team in the use of SAS for data management and reporting activities further ensures that appropriate data is utilized and results are reported effectively. The proficiency of the programmers in the development and application of SAS macros further enhances the quality and timeliness of the services.

The common tasks performed at Kreara using SAS are

• Data retrieval, management, and mining
• Basic data analysis
• Statistical analysis
• Report writing and graphics

The team of programmers keeps pace with the latest advancements of the software by being part of discussion forums, participating in conferences and training programs. Internal trainings and knowledge transfer sessions further help enhance the programming capabilities of the team members

Efficacy/Safety Analysis

Efficacy and safety analysis form the most important part of data analysis pertaining to any clinical trial study. Efficacy analysis involves statistical analysis to determine the effectiveness of the administered medication while safety analysis involves determination of the safety of the medication.

Kreara has extensive experience in carrying out efficacy and safety analysis for studies in various therapeutic areas. As part of the efficacy analysis, the services provided at Kreara are performing the statistical analysis and presenting related outputs. As part of the safety analysis, Kreara’s services include development of tables related to safety data like Adverse Events and Laboratory Data. SAS macros are developed for outputs related to safety analysis thereby ensuring quality and timeliness of the services.

The Statisticians, SAS programmers and quality personnel at Kreara work as a team to ensure that the outputs provided as part of the above analysis meet the client’s standard and timeline requirements.

Medical Writing

Medical writing refers to scientific documentation associated with clinical research and medical industry work. Kreara has well qualified and experienced medical writers with in-depth knowledge and outstanding reporting skills. The expert team of medical writers facilitates quality based documentation in compliance with ICH guidelines and the FDA/EMEA regulatory requirements. With its expertise, Kreara ensures providing well-defined documentation within the tentative timelines.

The various services provided by Kreara are

• Protocol Writing
• Statistical Analysis Plan
• Statistical Report
• Clinical Study Report

Trial Partnerships

Kreara offers clinical data management and biostatistical services that meet international standards thereby adding to the sponsor’s confidence in the execution of global clinical trials. Kreara works collaboratively with the world’s leading CROs ensuring effectiveness, efficiency and timeliness of joint processes and deliverables of complimentary yet interdependent services. A collaborative approach helps reduce both risk and cost incurred by mutual clients.

Kreara also offers training, certificate programs and support to CROs and clinical trial service providers through organized training programs. The comprehensive training programs enable CROs to successfully deploy resources and deliver services meeting global standards.

Some of our partner CROs is listed below.

CDISC Migration

Study Data Tabulation Model (SDTM) and Analysis data Model (ADaM) are two standard structures set by the Clinical Data Interchange Standards Consortium (CDISC). These standard structures are to be adhered to during data submission of human clinical studies to regulatory authorities like the United States Food and Drug Administration (FDA). This transformation of raw data of a clinical study to CDISC standards is referred to as CDISC Migration.

Kreara has an expert team of professionals with sound knowledge in these standard structures, corresponding implementation guides, CDISC terminologies and the related ICH guidelines. The team keeps track of the latest developments and changes by subscribing to newsletters, actively participating in discussion forums and attending conferences.

As part of CDISC migration, the team develops the specification document and the annotated Case Report Form (CRF), which present the mapping of variables from raw database to the CDISC standards. The team also develops SAS programs which actually map the data from the raw structure to the standard structure and the SAS datasets containing data as per CDISC standards.

Bio Equivalence Studies

Bioequivalence studies are designed to examine whether the systemic bioavailability of a test product and those of the reference product differ significantly. Bioavailability captures how fast the drug enters the systemic circulation (rate of absorption) and how much of the nominal strength enters the body (extent of absorption). Two pharmaceutical products are considered to be bioequivalent if their bioavailabilities, from the same molar dose, are so similar that they are unlikely to produce clinically relevant differences in therapeutic and/or adverse events.
 
Kreara has extensive experience in performing statistical analysis for Bioequivalence studies. The proficiency of SAS programmers further enhances the computation and presentation of results in an appropriate manner.

The services provided by Kreara in this area are

• Preparing Statistical Analysis Plan
• Computation of the Pharmacokinetic parameters using SAS
• Statistical analysis
• Statistical reporting of descriptive and Graphical summaries
• Integrated Final Report