Wednesday, May 5, 2010

Clinical Trials - Shift from Paper based to Software Systems

Clinical trials industry, shifts from paper work to software applications is the latest scenario one can notice with regard to the changes in the point of view of Clinical data management across the globe. Lets proceed with the business requirements and processing the clinical data in the latest clinical trials.

Clinical trials that have been concentrated over the earlier traditional model of paper based data management of the clinical research migrated to new approach of data management by opting software systems for its data management and all trial related processes wherein Electronic data capture, remote data entry are some of the examples.

Businesses in the present market that are in relation to clinical research are concentrating over several innovative implementations in order to reduce cost and time in lined with quality in place. New and advanced technologies came into implementation so as to manage the data of the trial.

As known, in general, earlier methods of data management in the process of clinical trials involved the manual processing towards the accumulation of the entire case report form, generating input screens and implementation of data entry methods that can be either single or double inlined with the maintainable data quality.

All these processes require the involvement of large human resources for data entry, data validation, data management, quality management where more capital is also required. In a more clear terms one can imagine these as the situations that led to a shift for software based processes.

The shift from the paper based approach to paperless clinical research with web enabled clinical data management, led to minimize the cost and time of the trial process and also further made it ease in managing the trial data.It ensured the sponsors across the globe for maintaining efficient, consistent data along with quality in place by using software systems like electronic data capturing at sites.

Clinical Research Organizations and pharmaceutical enterprises are moving confidently into various aspects of data management of the clinical study with the success of IT industry in managing data for pharmaceutical domain. Lets explore more in these areas in the later articles from our experts desk..

Monday, February 15, 2010

Clinical Functional Services - Overview

Management of the core aspects of the Clinical Trials can be achieved with an ease where functional services are involved. Clinical functional services gives an added advantage and additional support in handling the processes of clinical research.

It ensures sponsors of the clinical trials in influencing their expertise in clinical research with an insight from subject matter experts and senior management. Clinical Functional Service Providers gives a supporting edge in monitoring the trials and managing the entire data in the process of the clinical research.

When it comes to outsourcing the clinical trials, it has been a standard practice in the biotech and pharmaceutical industries and also companies strive to develop greater efficiencies and reduce timeliness, costs and resources .

Pharma and biotech companies are opting for this outsourcing strategy in some of the areas like regulatory document preparation, site identification and initiation, investigator contract negotiations, biostatistics, medical writing and more.

Functional Service provider (FSP) is one of the existing basic outsourcing model where Preferred Provider (PP) is the other. These models came into usage with the increasing outsourcing along with the industry.

For example consider some of the Functional Services :

  • Regulatory Affairs -Provides global expertise in streamlining the submission management and ensures in achieving fast product approval.
  • QA & Compliance -Quality Assurance needs to be critical and vital in GxP (GCP, GLP and GMP)
  • Clinical Monitoring -Clinical Research Associates perform comprehensive site management and monitoring activities in order to include the monitoring visits. For examples, Pre-study qualification visits, Initiation visits, Interim monitoring visits, Close out visits are some of the types of monitoring visits .
  • Medical Writing -A team of qualified and experienced medical writers bring out a wide range of regulatory, clinical, scientific and marketing communication documents that focus on core competency areas.
  • Clinical Data Management- Sponsors with centralized, coordinated data management handles all phases of clinical research. Data management plans accommodate each client's specific study needs. Clients may choose traditional paper-based or web-supported data-entry and data management.

On an overview , any enterprise that tend towards the usage of functional outsourcing may experience maximum success in lines of quality control and also have access to particular services at a minimum budget price.

Sunday, February 7, 2010

Good Clinical Practices - An Overview

Taken into account any clinical research, in which its discovery gateway lies in the development of latest diagnostic methods so as to identify drugs for treatment of diseases, clinical practices come into place. To be specified as Good Clinical Practices gives an in line picture of all the to-be followed principles in a clinical trial in order to make a well organized, risk free clinical research.

In order to make a well organized, success oriented research, businesses tend to have its quality maintenance in place and adhere to those stated as per the business requirements and talking in these scenarios a clinical research also have its quality to be kept into reality with Good Clinical Practices.

For any clinical trial where drug discovery is the ultimate requirement and in which, involvement of the human subjects is a must, Good Clinical Practices talk even about the health care, confidentiality of the human subjects in addition to the data management of the trial.

Similar to any other organization, Good Clinical Practices are related to the quality standards for planning, handling and documenting or recording trials. Having Compliances with Good Clinical Practices assures public that the rights, safety and well being of trial subjects are safeguarded and are in accordance with the principles and ensures that clinical trial data is presumptive.

Good clinical practices provides a standard and lays path to the acceptance of the clinical data by the regulatory agencies that are associated with the clinical trials and also ensures that the trials are in accordance with ethical principles.

These practices must be implemented in a way that any risks, inconveniences have to be identified and estimated before the start of the trial and a situation has to be ensured that expected benefits of the trial justify the risks.

As stated earlier, safety and health of the human subjects involving in the clinical trials must be the most important consideration. And the principle investigators or doctors need to be at most concentration regarding the health care, medical decisions of the human subjects.

In context to these principles of GCP many other principles like monitoring, confidentiality, approval of protocol of the trial are also in lined with Good Clinical Practices. This is just an overview of Clinical Trials good practices, There is no end to the discussion on the topic as this calls for continuous and effective innovative contributions to the subject. In coming days we shall have our experts say more on this.