Clinical Trial Data Management

sdinesh_kumar11@yahoo.com (Dinesh Kumar) — Thu, 29 Sep 2011 03:34:00 -0700

Clinical data management includes the entry, verification, validation and quality control of data gathered during the conduct of a clinical trial. Standard Operating Procedures explain the process to be followed in conducting data management activities and support the obligation to follow applicable laws and guidelines in the conduct of data management activities. A clinical data management system is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data collected at the investigator site in the case report form (CRF) are stored in the CDMS. To decrease the possibility of errors due to human entry, the systems employ different means to confirm the data.

The present day Life sciences industry demands flexible solutions to accelerate the drug development process on one hand while reducing costs of the clinical development process on the other. The most companies followed by this Clinical Data Management Services such as,

Clinical Data Management Services

Case Report Form (CRF) design
Database design and study arrange
Data entry and verification from multiple sources as well as paper, EDC,
Online data validation
Medical coding with MedDRA and other dictionaries
Medical Catalog
Protocol-wide database integration including legacy data, and standardization with new coding dictionaries

Bio Statistical Services

Statistical analysis plan design
Sample size calculations
Randomization schedule design
Interim analysis
Exploratory analysis and statistical modeling for efficacy and safety evaluation of drugs
Statistical support for publications and post marketing analysis
Integrated analysis of efficacy and safety

SAS Services

Creation of analysis database
Edit checks and database clean-up
Program synopsis tables, listings and graphs

Case Report Form Design:

Case Report Form (CRF) is the data collection tool for the clinical trial and can be paper or electronic. Paper CRFs will be printed, often using No Carbon Required paper, and shipped to the investigative sites conducting the clinical trial for completion after which they are couriered back to Data Management.

Electronic CRFs let data to be typed straight into fields using a computer and transmitted electronically to Data Management. Design of CRFs wants to get into account the information necessary to be gathered by the clinical trial protocol and intended to be included in statistical analysis. Where available, standard CRF pages are may be re-used for collection of data which is common across most clinical trials.

Database Design:

For clinical trial utilizing an Electronic Case Report Form the database design and make and CRF design are closely connected. The electronic CRF will allow entry of data into an underlying relational database.

For clinical trial utilizing a paper CRF the relational database will be built separately. In both cases the relational database will allow entry of all data captured on the CRF.

Data Entry:

When an electronic CRF is in use data entry is carried out at the investigative site where the clinical trial is guided by site staff that have been granted appropriate access to do so.

When using a paper CRF the pages are entered by data entry operators. Best practice is for a first pass data entry to be completed followed by a second pass or verification step by an independent operator. Any discrepancies between the first and second pass may be resolved such that the data entered is a true reflection of that recorded on the CRF. Where the operator is unable to read the entry the clinical data manager should be notified so that the entry may be clarified with the person who completed the CRF.

Data Validation:

Data validation is the application of validation rules to the data. For electronic CRFs the validation rules may be utilized in real time at the point of entry. Offline validation may still be required.

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Key Opinion Leader

sdinesh_kumar11@yahoo.com (Dinesh Kumar) — Fri, 23 Sep 2011 04:53:00 -0700

Association thought leader relationships has become a significant priority for Life Science companies. Key Opinion Leaders (KOL) is an important Thought Leader constituency for life science companies. KOLs interact with and expect coordination among variety types of users in life science companies such as clinical research, contract research, sales, marketing, medical education and clinical affairs. Key Opinion Leader (KOL) endorsement is essential for a product’s success throughout its life cycle. Pharmaceutical companies generally attach with the Key Opinion Leader early in the drug development process to give advocacy activity and key marketing feedback. The Pharma companies in cultivating KOLs allocate considerable time and money.

These functions are seldom bridged by processes, personnel or systems. This kind of a silo relationship frequently results in incomplete information about KOLs and leads to challenges in sales and marketing operations.

Key Opinion Leaders are,

• Leading physicians and scientists who are respected and acknowledged as leaders in a subject area

• vital to Pharma companies

• Influence thinking and treatment paradigms

• Give insight into diseases and treatment routine

• Give assessment of competitive therapies

Role of Key Opinion Leaders:

Like drug marketing strategies, the use of key opinion leaders is a worldwide phenomenon. We understand the following features are common among all the thought leaders irrespective of the therapeutic field.

• Drug Discovery

o Assist write the protocol and define efficacies of the drug during the study

• Medical Affairs

o Assist medical affairs on drug usage and defining side effects

• Marketing & Sales

o Take action as leading indicator of therapy acceptance

o Help in diffusion of information and can increase velocity of product adoption

o Physicians and institutions increasingly rely on KOL guidance for prescribing new drugs

They are experts in pinpointing and mapping the key opinion leaders on local, regional, and national level. KOL identification and profiling aides in the planning process of product commercialization by supplying the company with business intelligence from the key opinion leaders and their peers. They are expertly build catalogues of key opinion leaders which will have data in an easily passable, retrievable and quantifiable format. They will give you a comprehensive and complete list of key opinion leaders who are experts in areas like diabetes, cardiology, oncology and Alzheimer's research. Our KOL databases will have all the names who can easily tell what your research should focus and what are the target customers’ present needs.

Our Key Opinion Leaders Services include,

• Key Opinion Leader identification and mapping

• Primary Profiling (Biography capture)

• Complete Profiling

They offer Live KOL databases and also providing constant update of our KOL databases with their 24/7 support team. Our KOL databases are usually on Oracle, MS Access or Web based platforms. Our databases help our Pharmaceutical Clients in finding Clinical Investigators, experts and KOLs and also in marketing of new drugs.

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