The complexity surrounding labeling often leads to errors, product mix-ups, and even misbranding.

Labeling being an integral part of the quality management system, such errors often lead to product recalls which might have a negative impact on both the image and the finance of the company.

The best way out of this might be through digitization and automation.

Moreover, as the current scenario asks for remote working, this turns out to be the new normal.Labeling Content ChallengesLatest studies have shown that labeling content accounts for almost 33% of the product recalls.

Some of the challenges are: Delays in safety changes submission Delay in availability and updates of label superseded version and patient information Updating delays in national labels from core data sheet Issues with review and approval of Label change request Failure to timely update safety information and comments from Health Authorities Challenges with local and global RA teams’ priority issues

Drug Accountability of the Investigation Medication begins from the selection of location for its storage.

Issues with drug accountability are major and the majority of warning letters from regulators are a result of this.

Major delays are faced by sites for non-conformity and it often leads to non-acceptance of trial data.

IRT systems allow in streamlining such processes by keeping a single source of data and hence the process of Drug Accountability tracking becomes easier.Paper-based Drug Accountability ChallengesIt is the complexity surrounding the paper-based systems that makes them more prone to errors.

The Investigational medication documented as shipped should reconcile with the documentation of used and unused.

Records need to be maintained and staffs need to confirm that the contents that have been shipped match its previous record.

Supply Chain Management is one of the majorly effected streams due to pandemic which lead to low stock of the API to pursue the Manufacturing of the IMP for clinical trials.It's time to invest additional efforts on strategy development for managing the clinical supply activities in more efficient way.

The scope of the supply chain management can be made efficient by creating solutions to the current and anticipated challenges.As industry is also focused more on ‘Direct-to-Patient’ model, Drug Supply Chain Management has a primary role in this.Few areas of focus for DSCM include: Quality: Quality is of course one of the first and foremost key point that needs to be focused.

In DtP the concept basically relies on providing the Right Quantity of Supplies to a Right Subject at the Right Time in Right Condition.

Even though it’s not easy to perform these type of tasks during a pandemic, but can be handled efficiently using newer technologies.

Cost Effectiveness: The cost and the liability of the labor, logistics, and energy shall increase globally due to the current constraints.

Even though the budget of the running project is approved upfront,to run the operations effectively with quality, within the set budget, proper cost control plans should be executed through constant monitoring of the logistics and wastageRisk Management: To meet the needs of the subject according to the protocolcriteria proper Risk Management Plans shall be implemented.