Clinical Trials and Data Management

Clinical Data Management is a key business process in drug discovery lifecycle. Effective CDM ensures drastic reduction in time, from development to marketing, for all phases of clinical research.

Clinical Study Reports (CSRs):

We provide an in-depth analysis as well as preparation of an integrated clinical study report for your products in accord with ICH guidelines. Our team explores clinical study reports with special attention given to the inclusion and presentation of study-specific information and data. We help in developing a clinical study report for efficacy and safety trials with proper discussion of the format and structure of a study report for trials including pharmacokinetic and/or pharmacodynamic endpoints.

Case Report Form (CRF) Design:

Case Report Form (CRF) is the essential tool used in clinical trials that captures all the necessary data for each patient during a clinical trial. We assure that our experts work out all the mistakes as they work as a team in organized way and look after the following things while designing CRFs:

• Check logistics, design, and practicality of the protocol.
• Expedite accurate processing, analysis, and interpretation of data.
• Check protocol adherence.
• Fulfill regulatory requirements.
• Collect accurate data with all users in mind.
• Be clear and concise with data questions.
• Avoid duplication.
• Collect data in such a way that allows for most efficient computerization.
• It is user friendly.

In addition, we produce instructional documents for investigators and promote accurate data recording and query resolution.

Final Trial Reporting:

Our experts provide the complete trial reporting as per the protocol & regulatory guidelines in compliance with the Ethic committees, Regulatory bodies and the Sponsor requirements.

Site Initiation, Monitoring and Closeout:

Our Study monitoring team assures you the following:

• Verifies if Informed Consent was taken and the process documented per requirements
• Reviews ICFs, patient files, lab reports, IP administration procedures to confirm if they are as per the protocol & regulatory guidelines
• Verifies compliance with the EC, Regulatory bodies and the Sponsor requirements.
• Checks if changes made to the CRF were made by authorized study staff and have been signed and dated.
• Ensures all Safety related data has been captured (SAEs, ADRs, IRAEs etc)
• Completes a Site Visit Log

Database Design and Development:

A database is a set of data, organized for easy access. The database is the actual data. Databases use a series of Tables to store the data. When thinking about good database design, it is important that you keep data retrieval, storage and modification efficiency in mind.

To create a database, a lot must be known about the data that will be put into the database, the data-access patterns, and the database's volume of activity. Our team helps in designing an informative perfect database by following activities such as:

• CRF annotation
• Program and project definition
• Study definition
• Defining data collection objects
• Testing database
• Validation and Derivation Procedures
• Data Extract View Template

Data Entry and Reconciliation

Our Data entry team works in responsible way for identifying logical, system and study specific errors, along with case particular discrepancies and resolving the same as per study requirements and client specifications. They are also responsible for ensuring data quality, process optimization & meeting CDM deliverables. We follow a Standard Data Entry Process which includes:

• Forecasting about the CRFs (Case Report Form).
• Receiving CRF & Tracking
• Front Sheet
• Allocation of the CRF for First and Second pass entry.
• Work out Project Specific Guideline for entering CRFs data.
• Special Codes
• General Guidelines (Date Formats, Time Formats & Page By Page Guidelines etc)

Clinical Data Coding:

Clinical data coding is an integral part of Data Management and is a process of matching text collected on the CRF to terms in a standard dictionary. We ensure you that our team undergoes intensive quality checks, performed as per the Data Coding Guidelines which includes converting and reporting of specific data collected from Clinical trials to standard terminology in order to generate very high and reliable data. Clinical Data Coding forms a foundation for Statistical Analysis of Clinical data in every project and is based on SOPs followed for the data coding operations.

Multiple Data Collection Choices: Fax, Paper, EDC:

Data vary from project to project and is also dependent on the type of data collection tools and methodologies. The data could be from Case Report Form (CRF), which are entered manually or Non-CRF (Laboratory, ECG patient diary, questionnaires, medical images, etc., which are simply uploaded and imported onto a Clinical Data Management System (CDMS). Our experts provide you acquisition or collection of clinical trial data through various methods such as:

• Paper or electronic medical records
• Paper forms completed at a site
• Interactive voice response systems
• Local / Electronic Data Capture (EDC) systems

For further information contact: info@adicro.com