Clinical Research Services

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Clinical Data Management

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. This whole process utilized for Clinical Data Management process. Now I just find out the one concern provide from this overall above process. They provide a good and efficient Clinical Data Management Services across the globe. I mention the contact details: [email protected]

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Key Opinion Leader

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 leaders 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

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

Medical Affairs

Assist medical affairs on drug usage and defining side effects

Marketing & Sales

Take action as leading indicator of therapy acceptance

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

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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