Covid-19
 

3 Barriers to Writing Automation & some Solutions

October 01, 2020

At the high-impact R&D end of life sciences, investment in technology is consciously linked to commercial priorities including innovation, efficiency.

3 Barriers to Writing Automation & some Solutions

Labeling Regulations/Exceptions during Covid!

September 30, 2020

Several global regulatory and health agencies issued guidance with regards to the conduct of clinical trials during the COVID-19 pandemic.

Labeling Regulations/Exceptions during Covid!

Measures to Overcome Low Stock Supplies in Clinical Trials Using IRT


Management of clinical supplies in clinical trials has become a major hurdle in this new era of clinical research. With the complex challenges that clinical trials.

Measures to Overcome Low Stock Supplies in Clinical Trials Using IRT

UDI & EUDAMED Explained under EU MDR

September 25, 2020

Unique Device Identification (UDI) intended to assign a unique identifier to medical devices within the United States, it marks and identifies individual medical devices.

UDI & EUDAMED Explained under EU MDR

Main Factors that Unify IRT in Clinical Supplies


IRT has created its footprint in the field of clinical research and has evolved drastically in such a way that it has bought a major difference in perspective of clinical trials over the decades.

Main Factors that Unify IRT in Clinical Supplies

Label Tracking: An Important Aspect In Production Distribution

July 30, 2020

Drug labelling has changed over time because of evolving regulations and has increased in content and length, with a standard format to guide the safe and effective use of the drug.

Label Tracking: An Important Aspect In Production Distribution

Reluctance of Regulatory teams embracing AI

July 20, 2020

One of the key regulatory problems that are hindering the acceptance of AI in Bio-Pharma is the apocalyptic prediction about Human jobs being traded by machine intelligence.

Reluctance of Regulatory teams embracing AI

Importance of DSCM in Managing Clinical Supplies during COVID


It's a known fact that the Pandemic Effect of Covid-19 apart from creating the hurdles in Clinical Research has also fetched a possibility to many of the new innovations.

Importance of DSCM in Managing Clinical Supplies during COVID

Challenges with Labeling Content, QC & Tracking - The Way Out

July 9, 2020

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.

Challenges with Labeling Content, QC & Tracking - The Way Out

Ensuring Drug Accountability Compliance with IRT


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.

Ensuring Drug Accountability Compliance with IRT

Future LABELING: Data Digitization, Structure and Automation

June 1, 2020

Labeling process prominence has increased over the years and manufacturers are trying to manage product labeling & artwork at the same time while maintaining end-to-end life cycle changes of product labeling.

Future LABELING: Data Digitization, Structure and Automation

Data Integrity in Clinical Trial through IRT


Integrity of data is ensured only when initial remains valid throughout the product life cycle. If the accuracy comes under question at any point in time then data integrity would collapse.

Data Integrity in Clinical Trial through IRT

Future Clinical Technologies - Automation & Analytics

May 15, 2020

Current situation has led the world to remain secluded and engage more into remote activities. In such situations, like most other industries, healthcare industry too has been forced to think out of the box.

Future clinical technologies - Automation & Analytics

Start Small & Smart with Regulatory Automation

May 08, 2020

Companies who did large implementations (like RIM, EDMS, Change Management, ERP, others) have all noticed their costs and timelines doubled than what is budgeted initially.

Start Small & Smart with Regulatory Automation

Clinical Trials through ‘Direct To Patient’ in COVID-19


The COVID-19 pandemic has taken a toll on the entire world affecting various sectors including the pharmaceutical industry. Unlike the other industries, the pharmaceutical industry has not come to a halt because of its need in such difficult times.

Clinical Trials through ‘Direct To Patient’ in COVID-19

Medical Device Labeling Regulation Changes by FDA for COVID 19 period

April 16, 2020

FDA is committed to providing timely guidance to support response efforts to this pandemic situation of COVID-19. In this regard FDA has implemented few guidance documents immediately without prior public comment, because this is not feasible or appropriate at this pandemic time...

Medical Device Labeling Regulation Changes by FDA for COVID 19 period

FDA/EU/MHRA/TGA Clin monitoring suggestions COVID


There are several suggestions, recommendations from different health authorities for sponsors to handle clinical trial aspects during this very challenging time of COVID. Most of them recommended not starting any new studies for time being.

FDA/EU/MHRA/TGA Clin monitoring suggestions COVID

For Labeling Teams, What Does 10 Minutes Saving Per Day Means?

February 26, 2020

That’s 40 hours time saved per year. The more per day time saving, obviously means more time saved in addition. Use this time that you’ll save for your strategic planning, process optimizations, improvement planning, or more coffee indulging breaks or relaxing yoga time …

For Labeling Teams, What Does 10 Minutes Saving Per Day Means?

Most Common and Avoidable Mistakes While Adopting ISO 13485

February 11, 2020

In the process of implementation of QMS standard ISO 13485, many companies face common struggles; however their mistakes can be avoided when you look and analyze these things more closely. The more closer you look at the QMS requirements.

Most Common and Avoidable Mistakes While Adopting ISO 13485

Regulatory Data and Info Management for Med Device Success

January 31, 2020

With EU MDR changing the plain field of med devices to a whole a new level, other countries are following similar path of increasing demands in product safety, traceability, performance areas. Companies not organized on information management with a system.

Regulatory Data and Info Management for Med Device Success

Effectiveness and Flexibility of Adaptive Designs in Clinical Trials


Drug development is becoming a complex process with each passing year. Expenses and time are not at per. Even success rates are dwindling over time and hence new drug development too loses the charm. To cater to such situations, adaptive designs are implemented.

Effectiveness and Flexibility of Adaptive Designs in Clinical Trials

Labeling of Pharmaceutical Products: Challenges and Standardization

December 10, 2019

Labels of pharmaceutical products act as an “instruction manual” to the end-users hence need to be standardized. This standardization process is often met and overcome multiple obligations like compliance issues, failure to timely update labels, non-compliance risks and so on.

Labeling of Pharmaceutical Products: Challenges and Standardization

Linked Labeling: Maximizing Content Management Complexity?

December 03, 2019

Content management is becoming a burden for the life science industry when it comes to labeling. The interdependency of all the phases has a negative impact on the revenue, the rate of sales, market entrance and often leading to rejection of registrations.

Linked Labeling: Maximizing Content Management Complexity?

Effective Regulatory Change Management with Reg Intel Equipped RIM Tech

November 28, 2019

The Medical Device Industry is undergoing a rapid change with an increase in the volume of regulations. Regulatory change management is an amalgamation of quality, compliance and risk management.

Effective Regulative Change Management with Reg Intel Equipped RIM Tech

Top Trends of Enterprise Labeling in 2019

November 14, 2019

The market scenario of drug and device labeling is evolving rapidly and is evident with the FDA’s mandate PLR, PLLR drug labeling guidance, 21 CFR PART 801 general device labeling guidance.

Top Trends of Enterprise Labeling in 2019

Reg Information/Data for Devices, very important going forward!

October 21, 2019

Every day device manufacturers face challenges, especially if they have products in multiple countries. This can be from business needs or local demands or regulatory compliance that needs to be maintained for those countries.

Reg Information/Data for Devices, very important going forward!

Integration & Reconciliation IRT Guidelines


IRT’s main function lies in Supplies Distribution throughout the study and acts as a Medication Assigning Tool during Randomization/Enrollment. IRT is designed in such a way that it captures only the minimum required data fields that are useful to carry out its functions.

Integration & Reconciliation IRT Guidelines

Technology Towards an Efficient Monitoring of Clinical Trials

September 23, 2019

Clinical study and technology are two such genres that are progressing at a rapid rate. The implementation of age old practices does not suffice in any of the scenarios. Clinical trials are common in pharmaceutical industries and they occupy a major part in the approval of a drug.

Clinical Trial Monitoring Technology

Bulk/Non-Uniquely Number Kits in a Study


If the Kits in a study are not identified with a unique number (Kit Number), then the study is intended to make use of the advantages of Bulk/Non Uniquely Numbered Kits. This concept of Kits can be generously used to distribute and assign blinded Kits, like Open-label Rescue medication, Run in Kits.

Clinical Studies

Labeling Changes & Challenges to Comply with EU MDR

April 24, 2019

The introduction of European Medical Device Regulation (EUMDR 2017/745) gives great importance to the end user to assist with the safe and proper use of a medical device(s). The EU MDR and other UDI-type of regulations is causing more and more medical device companies to revisit their labeling processes.

Structured Product Labeling

We are Direct to Subject Ready


The advantages of the D to S is multi faced for Subjects, Sites, CROs and Sponsors. We recognized the increasing significance of D to S which inspired us the build this features into our system. Our D to S is build to overcome unique challenges that come with this model.

Configurable IRT system

Clinical Trial Supplies Accountability


To account all the supplies of Clinical Trial is a regulatory requirement. Traditionally people used to use paper based or Excel based tracking of the Supplies. This is tedious, time consuming and error prone. DDi has built a robust and plug and play Supplies Accountability module into its mIRT.

Clinical Trial Supplies

Digitize Instructions for Use (IFU) to Comply with EU MDR

Mar 13, 2019

EU MDR is turning digitization on its head. This new regulation, which goes into effect May 26, 2020, is inducing digitization back to the forefront. EU MDR aim to enhance medical device safety and effectiveness and to realize this, the new regulation requires the use of eIFU.

Digitize Instructions

Clinical projects (you or your vendors/CROs) are putting them at Risk by 80%...


If you know your risks, I’m sure you or your teams manage them well (with KRIs or thresholds or logs or trackers). Question is what are you doing about the remaining 80% of risks. Most companies leave this key part to either untrained teams or vendors (and some of vendors doesn’t know risk management except to update a risk log before audits).

CRO Performance & RACT tool

Why Combining Performance, Oversight, Risk and Compliance are very important for your Clinical Development?


Unfortunately, most sponsors and CROs use multiple applications to manage their clinical studies. Integrating multiple applications may be challenging for example reporting through multiple apps, managing data & content across systems, limited collaboration, ease of use, Compliance with standards and the list goes on.

Oversight, Risk and Compliance

Why sponsors should opt Configurable IRT system, before opting any custom version?


Clinical trials are more complex than ever and a robust, reliable & cost efficient clinical supply strategy is vital more than ever before. The number and complexity of issues affecting supply chains have also grown to include costly comparative drugs, intricate protocols, delicate investigative compounds, adaptive clinical trials

Configurable IRT system

Are You Aware of Other Countrie's Regulatory Requirements?

October 29, 2018

To enter into a market, biopharmaceutical companies should have information of local regulations irrespective of the type of drug. Tracking the local regulations of semi and non-regulated markets are the biggest challenges for an affiliate as there would be certain changes expected frequently in regulatory world.

Countries Regulatory Requirements

Start small and smart with Labeling Automation

October 01, 2018

Companies who did large implementations have all noticed their costs and timelines doubled than what is budgeted initially. Yet, PwC's 2017 effectiveness benchmark report found that users spend half their time focused on mundane, repetitive tasks of gathering data from various systems. This led to many of the systems reaching the point of diminishing returns.

Smart  Labeling Automation

How are you managing your medical devices Regulatory Information?


Is your team still using Excel sheets, or other functional teams tools (such as registration trackers or ERP) to manage your global regulatory Health Authority / Notified Body compliance activities? Learn why these tools pose either compliance or business risks if you manage your regulatory activities.

Manage your Medical Device Regulatory Information