Clinical research trials are performed in order to evaluate the effectiveness and the safety of medications by monitoring their effects on large groups of people. A Clinical Laboratory indulges in acute discovery of drugs as they are conducted for the benefit of the people nationwide. However, they can not at any stage afford to be careless, as the research puts life of many human beings at stake.

 

Nevertheless, with an advancement in the clinical Laboratory work schedule, now the Laboratories are also transitioning into becoming IT hubs. Clinical Laboratories opt to embrace every good technology that can enable them to enhance the speed of their Clinical Trials at the earliest.

 

With the technologies such as IVRS, EDC (Electronic Data Capture), ERP/MRP solutions in line, LIMS (Laboratory Management Information System) has become a central clinical Laboratory software.

 

Clinical Laboratory Software by MegaLims is a solution that takes care of all the functions of the enterprise and Laboratories. It looks after all the minute chores and manages them efficiently so that they are followed in standard processes.

 

The key benefits of using MegaLims in Clinical Laboratories are:

 

• MegaLims facilitates Automated access of Information throughout the clinical Labs
• Fast data Tracking for patients, Drugs, CTM and other data.
• Cost effectiveness in terms of employment of less resources and multiple software for central Lab management.
• Time savvy – Track down the data with only a few clicks, saving precious time and pressure for random manual searches.
• MegaLims being a web-based application enhances round the globe access for multi-site clinical trials, through any web browser with user specific account.
• Clinical trials can customize MegaLims for acquiring an Automated service of CTM (Clinical Trial Management).
• MegaLims has been specifically built in accordance with all the Regulatory authorities (like FDA-21 CFR Part 11 Compliance, GCP-ICH). This way, clinical trial management teams and authorities can be free from all worries and concerns of going wrong anywhere.

 

MegaLims Software and Clinical Laboratory

 

MegaLims for clinical Laboratory management provides a simple and flexible approach for even the most complex clinical problems. The system focuses on the need and requirement of Lab processes and workflow. The best part about MegaLims software is that it is extremely adaptive to client's request. This way it can be modified quickly to suit specific Laboratory needs.

 

Patient Management using a Clinical Laboratory Software

 

For any clinical Lab, the first priority is essentially given to it's patients. This is because patients are the major sources that enable the Labs to develop as well as achieve any drug related research target. A patient can directly influence the outcome of any research and so are subjected to minute scrutiny. That is why it becomes significant for clinical Labs to manage it's patients and maintain their records in a well-organized format.

 

MegaLims makes data entry and all the operation related to patients electronic. MegaLims also centralizes their tracking, so that they can be accessed easily at any point of time. The software keeps track and automated entries of Patient records in the following aspects of Clinical Laboratories.

 

Data tracking & maintenance for patients in clinical trials

 

• Patient Screening Data- The data of all the processes involved in patient screening and the tracking of data of the patient evaluated for screening.
• Patient Randomization- Records of Patient enrollment and randomization, Schedule Randomization, Informed Consent, Patient History.
• Patient Status Management - Patient Query, Patient Discontinuation, Patient Unblinding.
• Patient Diary Management- Patient treatment history and records of the treatment assigned.

 

Drug Maintenance using clinical Laboratory software

 

In Clinical Trials assignment of drugs to patients or volunteers participating in the trial is a task that is to be followed religiously. MegaLims streamlines this drug assignment process as well as keeps check on the existing drug data. MegaLims also ensures that every drug that is delivered and the details related to it are properly entered in an automated Clinical Lab worksheet. The worksheets by MegaLims can be customized to become user friendly. They contain areas such as:

 

• Drug Composition
• Indication Of Drugs
• Adverse Effects from the drugs intake
• Side Effects associated with Drugs
• Warning

 

The application of Laboratory Information Management System by MegaLims in Clinical Laboratories increases the progress of clinical trials. The software makes the results much more efficient and accurate, thereby easing the unnecessary workload over the staff.

 

Clinical Trial Management using Clinical Laboratory Software

 

MegaLims Lab Information Management System (LIMS) software administers all the tasks related to Clinical Trials and centralizes them with a standardized defined process.

 

The basic system of management of clinical trials is Logistic & Inventory Management. MegaLims Logistic & Inventory Management makes Clinical Lab Operations faster and on time delivery of the targets and other itinerary managements such as:

 

• Storage Management
• Monitoring of Expiry Dates
• Label Tracking
• Return of Study Products

 

MegaLims traces all the logistics associated with Clinical Laboratories in terms of Drug Tracking (such as expiration and quantity), Drug Shipment Request, Drug Review/Reconciliation, Drug Code Loading, Site Code Loading, Spillage and Breakage Reports and Scheduled and Unscheduled re-supplies. The automation of all the Logistics and Inventory under MegaLims eases the pressure and manual effort that Clinical Labs incur in making an efficient management.