Covid-19
 

3 Barriers to Writing Automation & some Solutions

October 01, 2020
Regulatory Automation

At the high-impact R&D end of life sciences, investment in technology is consciously linked to commercial priorities including innovation, efficiency and speed to market. There is an appreciation of the value of automation in administering and reporting on clinical trials, for instance. Here, smart use of technology to accelerate what would otherwise be labor intensive manual processes ensures that data representation (in form of documents/reports) is robust, bears close scrutiny, and doesn’t tie up more skilled resources than is absolutely necessary.

Writing (Medical, Regulatory, Safety, Scientific, CMC) is an art of science. Here comes the conflict of automation which is seen as “inhuman”. But as requirements are multiplying every day, how can companies manage the load without increasing resources or resorting to outsourcing or offshoring ?

All Writing teams want to spend time on “science” or “innovative projects” and not seen as a ‘cost center’. With these objectives and workload increasing, a case for technology enablement and automation is strong. So, what is holding companies back from investing in writing automation?

Below are three of the most common perceived barriers to technology-enabled writing automation, and how and why they should be addressed at the earliest.

1. A lack of "Writing" friendly enterprise solutions

Look at most other industries, especially those that are highly regulated, and use of IT systems tends to be highly evolved. That’s because organizations have long realized the inefficiency (in cost, time and resources) of using people to manually input data into core business systems, and then physically re-enter the information into adjacent systems in other departments.

In pharma, by contrast, "EDMS" and "Word" are the only and dominant tools provided to Authors. EDMS (whether on premise or cloud) may provide some help like versions, tracking, collaboration, but doesn't address the bulk of manual heavy lifting that needs in Authoring. Same with WORD in spite of adding some plugins and other macros.

Some companies tried (and realized it didn’t helped) is Structured Content Authoring or XML editors. These are pretty good solutions from Tech point of view, but they are not intuitive to Writing world. Authors cannot relate (or may even get irritated sometimes) to terms these tools use like fragments, rules, components, variables, inheritance and so on.

In some cases, the issue is that Writing departments (whether medical or clinical or CMC) lack access to relevant technology expertise and knowledge, so they don’t have a picture of what’s available or what’s possible – including the scope for sourcing solutions and optimized business processes via cloud-based platforms and relationships with technology vendors. Meanwhile, larger companies which do have sufficient internal resources often believe that they need to build any tools themselves, something they may never get round to – especially if they haven’t tied down a proper business case & ROI

Given that some very intuitive and easy-to-integrate writing tools do exist out in the external market, with the precise purpose of assisting in improving writing efficiency, it seems surprising that sponsors do not make more use of them – especially as the time and cost savings associated with digital solutions are shown to exceed 60 per cent when compared with processes that rely on manual writing alone.

2. Cost

For reasons mentioned earlier, writing does not tend to attract big budgets. This means that any investment in Writing management IT needs to be tightly targeted, and seen to deliver improved results with greater efficiency. If companies choose not to invest in transforming Writing activity, they risk spending more than they need to, and consuming too much time of busy people who have other more critical tasks to be getting on with.

While large companies, may question the cost/benefit trade-off of creating new automation aids, their internal development is not the only option. Taking advantage of a pre-existing pre-tested tool that’s ready to go today and accessible on demand via a software-as-a-service delivery model, changes the economics considerably – especially if there is no associated support burden, because the vendor takes care of everything.

3. Usability issues

Companies’ inertia when it comes to trying new technology often also comes down to an aversion to change, of having to behave in different ways which may require resource retraining. Tools’ intuitive ease of use is paramount in overcoming this very real barrier.

In Writing, it follows that tools need to be easy and intuitive. If users were able to author, verify all data needed at one place, cross-check source data, content impact, simple work-flow– this could be transformational in itself. For writing departments, this improved user engagement ought to result in more complete and more reliable documents, captured in a timely fashion and reducing the burden on authors to chase up right data or information or any lack of clarity.

Why wait?

Looking for discrete tools which are very easy to adopt and use, and which alleviate a substantial manual administrative burden – are a good way for companies to test the potential of writing automation and amass some experience.

Embracing greater automation is going to be essential as writing/reporting requirements continue to multiply and grow, placing an ever greater strain on resources. Automation offers a way to cope with rising demand, and to simplify demanding routine tasks, as companies expand their product mix and market coverage, while maintaining regulatory compliance.

Yet, to take full advantage of the opportunities, companies need to overcome their historical barriers to technology adoption – and there is no time like the present.

 

Labeling Regulations/Exceptions during Covid!

September 30, 2020
Labeling Automation

Several global regulatory and health agencies issued guidance with regards to the conduct of clinical trials during the COVID-19 pandemic. This swift action taken by the regulatory agencies was in direct response to global concerns around assuring the safety of clinical trial participants, maintaining compliance with GCP and minimizing risks to trial integrity during this unprecedented time.

ZERO Guidance or Regulations given by any agency for Labeling exceptions. That means whether your regional teams are disrupted because of Covid, teams cannot follow-up labeling changes on time or people doing WFH, or other changes, your labeling obligations remain SAME, if not increased more

Label compliance may not be high priority for your compliance teams or health authorities or some of you as there are other priorities. When dust settles, some of your Labeling gaps might pose major challenges and companies will have to incur extra costs to bring any label non-compliance to order. From studies in the past, for a business, the consequences are costly, with the average label change sitting at $350,000.

In addition, the risk of non-compliance is significant. From the potential regulatory fines and loss of brand reputation, temporary forced shutdown of a full production line and cost of re-mediating, not having a validated system and process in place could have a potentially catastrophic impact on business.

Labeling Digitization to Rescue

Digitization & Automation offers traceability that not only mitigates potential risks but also drastically improving labeling efficiency.

For existing labels, with the help of inbuilt translation engine, reverse translations can be done on existing regional/country labels and compared to either CCDS, USPI or SmPC. This will help identify existing gaps / violations faster without having to execute “special” compliance projects saving cost an reducing pain for the teams (as labeling teams don’t enjoy doing these tasks anyways)

For future labels, technology will help in achieving a comprehensive view of labeling operations and touch points in relation to the rest of the organization minimizing your attempts to resolve any issues in isolation. With Label Content digitization, changes and life cycle can be managed holistically, rather than managing with out-dated process of managing labels/documents following painful processes of maintaining versions, copies, track modes etc.

With the ever changing landscape of labeling technology, there are now solutions on offer fit for every type of organization at all budget ranges giving modular options. Yet, for many who get satisfied with an EDMS, the implementation of these newer tools/technologies is still accompanied with apprehension (for some lack of time and for others control issues). These automated solutions can end the recurring insanity of labeling challenges. Digitization & Automation will help future proofing operations within the overall labeling supply chain.

 

UDI & EUDAMED Explained under EU MDR

September 25, 2020
ViSU

What is UDI?

Unique Device Identification (UDI) intended to assign a unique identifier to medical devices within the United States, it marks and identifies individual medical devices throughout their distribution and product life-cycle. Initially, the UDI system was created, developed, and maintained by the device manufacturer based on global device identification standards. Today, it also helps with procurement and reimbursement.

With certain exceptions, every medical device label needs to have a UDI mark and be composed of two parts:

  • Device Identifier (DI) - a mandatory, fixed portion of a UDI that identifies the specific version or model of a device;
  • Production Identifier(s) (PI) – a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device. This will be dependent upon the manufacturer’s internal quality system. •   lot or batch number within which a device was manufactured; •   serial number of a specific device; •   expiration date of a specific device; •   date a specific device was manufactured

Therefore, UDI = DI + PI.

What is UDI?

UDI History

In 2007, the U.S. FDA developed a labeling system that would uniquely identify every single medical device (MD) on the market. The Global Harmonization Task Force (GHTF) soon recognized the global relevance of such a system and adopted respective guidance that was last released in 2013 by the International Medical Device Regulators Forum (IMDRF), international cooperation of regulators made up of industry stakeholders and GHTF successors. (Interestingly, Medical device manufacturers experienced in the U.S. market have quickly recognized the similarity of the EU regulation as compared to the U.S. Food and Drug Administration’s (FDA) UDI guidelines.

Following the global trend in handling the trace ability of medical devices, the EU Commission has clearly defined the requirements for the implementation of a Unique Device Identification (UDI) System in the final text of the new EU Medical Device Regulation (MDR) 2017/745.

The EU UDI System, like the U.S. UDI requirements, will be implemented in phases, starting with the highest risk classes first, and lowest risk classes last.

UDI History UDI History

Key Differences between US GUDID and EU EUDAMED elements

EUDAMED will be an information system for exchanging legal information related to the application of European Union Directives on medical devices between the European Commission's Enterprise and Industry Directorate General and the Competent Authorities in the European Union Member States. Its legal basis is laid down in Directives 90/385/EEC, 93/42/EEC, 98/79/EC, and 2000/70/EC.

Under these Directives, Member States need to ensure that medical devices that are placed on the market and put into service comply with all provisions of the Directives, including the ‘essential requirements’, and that no obstacles are encountered for the free movement of approved devices. The Directives also require that data be stored in a database in a standardized format. The EUDAMED project aims to address the effective implementation of this provision of the Directives.

Following are the common elements between GUDID and EUDAMED but they likely need to be translated into 24 official languages of the EU:

  • Name or Trade name
  • Additional product description
  • Clinical size
  • Storage and handling conditions
  • Additional trade names of the device
  • Critical warning or contraindications

Deadlines for UDI implementation

Unlike GUDID, EUDAMED is adopting a risk-based approach for UDI submissions.

  • Below are the UDI implementation dates according to the class: •   Class I: 26 May 2025 •   Class IIa and IIb: 26 May 2023 •   Class III: 26 May 2021 •   Implantable devices: 26 May 2021
  • For IVDs, the implementation will also be risk-based but delays in the implementation of the IVDR timeline will be different. •   Class D devices should be compliant by 2023 •   Class C & B devices by 2025 •   Class A devices by 2027

*These compliance deadlines are subject to change as the fulfillment of the requirements is dependent on the progress of the EUDAMED implementation and its availability

 

Measures to Overcome Low Stock Supplies in Clinical Trials Using IRT

September 28, 2020
Clinical Trial Supplies Management

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 shoot in terms of the design or the study population or the subgroup categorization has put the supply chain managers in a critical pose.

IRT shall ease the work of the Supply Chain Managers by taking prior measures of a few main factors that hamper the management of the clinical supplies at sites. The new designs in the clinical study conduction involve the multi-centers that are in National and International locality.

A few of the main factors to be considered to take appropriate measures are:

  • Maintaining an adequate quantity of supplies at site by the time the site is activated and the enrollment process is initiated.
  • Taking appropriate measures to ship the supplies to multi-sites located nationally & internationally.
  • Maintaining and shipping the supplies that are safe and not meeting the expiry in near future.
  • Shipping the supplies by meeting the regulatory guidelines and standards.

IRT measures to overcome the Low Stock Supplies at Sites:

  • As many of the studies are designed as multi-centric sites that cover various geo-locations, IRT shall capture the proper Leads days required to deliver the right ancillaries to right site at right time.
  • To maintain adequate stock of supplies at sites by the time the enrollment process is initiated at particular sites, IRT shall initiate an advance shipment of required supplies to the site when the site is activated or the first subject is screened.
  • As the duration of the study is long there is always a chance of shortfall of the supplies and they reach the expiry. To overcome this hurdle of the supplies reaching the Expiry leading to a shortfall of the supplies for the study, IRT shall plan in advance to notify the shortfall of the supplies and also regarding the expiry of the supplies which enables the supply chain managers/sponsor to plan their activities well in advance.
  • As the charges of the shipment of supplies are going beyond the budget of the actual project, IRT shall take proper measures to meet the budget of the project by planning the shipment in such an organized manner where unnecessary shipments are avoided using its settings of check range, restock range, trigger value and resupply value.
  • There is always a chance for regulatory to raise a query regarding the shipment of the IMP’s which shall delay the supplies restock at the site, IRT shall ship only those IMP’s from a particular lot’s for which the country submissions are provided as per the Regulatory bodies and which shall not delay the process of shipment.
  • The site can reach to low stock at any level of the study that shall hamper the process of study continuation.To meet this clause IRT has come up with some new settings of auto orders. This will generate automatic shipments in advance once the site reaches the set level of the supplies at site that shall not allow the site to reach out of stock.
  • As communication is the main bridge for any trial between the sponsors and stakeholders, considering that IRT has been designed with a separate functionality of Alerts & Notifications which shall communicate every user regarding the activities of the study and also alerts sponsors and Supply chain managers regarding the low stock levels at site, expiry of the supplies and shipment details.

Any challenge related to supplies in clinical trials can be faced with proper planning, assuming the risks & challenges in advance and, also maintaining continuous communication with the study team and sponsors.

 

Main Factors that Unify IRT in Clinical Supplies

September 24, 2020
Clinical Trial Supplies Management

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. It faceted itself into the streams from only randomizing the subject and assigning them to a treatment group to managing the overall supplies required throughout the study through supply management.

Multiple factors fall in line to manage the supplies throughout the study, where few of them are the number of subjects expected to be enrolled in each site, the number of days the shipments reached the site physically, etc. These factors help the system to develop algorithms that will monitor the supplies existing at site, supplies required at site within a month, and many more. These algorithms are more essential for an IRT system to function in such a way that there is no low stock of supplies at site. Few main facets that enable the IRT to function effectively are discussed below.

  • Initial ordering of Supplies: This is one of the main facets that enable the function of supply management. This facet functions through various factors like site activation, subject screening settings. The supplies shall be distributed to sites based on the predefined parameter settings given to the system. To perform the activities of a subject, there requires a sufficient quantity of supplies. Those requirements are fulfilled by the initial shipment settings. Based on a few factors initial shipment to sites shall be raised either when the site is activated or when the first subject is screened at site, which shall prepare the site to perform the further activities of subjects screened flawlessly.
  • Auto Ordering of Supplies: This is one of the most important facets for managing the stock of supplies at sites. The auto orders shall be raised as on when required to meet the predictive needs and non-predictive needs of the supplies at site. These settings shall be site-specific and designed based on the parameters like recruitment rate of the site, trigger value, resupply value, check range, and the restock range. The predictive needs of the site are fulfilled through predictive settings given to the system.The System shall check the values given and raise the shipment accordingly with the required quantity of kits with kit types from the lots. The non-predictive needs of the site are fulfilled with the buffer settings given to the system. System shall raise the shipment according to the values provided. This way the IRT functions effectively to maintain the supplies at each site.
  • Safety Settings: These settings play a vital role at supply level and site level. These settings are designed in such a way that the expired supplies are not reaching the subject in any way. Maintaining the expired supplies and shipping them is a waste of resource, time, and cost too. Each shipment is very important and it shall be planned in such a way that the budget of the project does not affect in any way. These safety settings and auto-order settings shall add value to the tool in customizing the shipments as per the requirements and unnecessary shipments are not raised. The shipment or dispensing of the expired supplies is halted with parameters like DND (Do Not Dispense), DNS (Do Not Ship) & DNC (Do Not Consider) which are core terms in IRT.
  • Site Activation: This one of the core steps to be performed, as all sites, shall not be activated at a time. As per the regulatory and the success of SIV a site shall be activated. This action requires authentication as there shall be an initiation of supply to the site once it is activated. Once the site is activated, the site shall be enabled for the screening activities, randomization activities, and supply-related activities. The Site needs to be configured with all the data as per the protocol before activating. Once the site is activated, the system shall raise the initial shipment as per the settings provided, the request of the shipment would include the number of kits from the defined lot, expiry date, site details so that the supply manager shall record all the data and ship the required kits physically. Supply activities of the site include the acknowledgment of shipment once received at site.
  • Tracking of the supplies: Tracking of supplies is one of the main focus points of IRT. Even though it does not track the live movement of the supplies, there is a passive way of tracking which shall deal with the change in the status of the supplies as when required. The System shall have a different status for the orders and the kits. These statuses shall be permission-based and only the desired personal shall change the status so that it is recorded and tracked in the system.
  • Multiple depots and sites shipments: The distribution of supplies in a clinical trial is not only defined for a single site or depot, it involves many sites and depots. It can be both depot to depots, depot to sites. Each site shall be assigned to a depot for supply-related activities. The supplies for that particular site shall be maintained by that depot which shall be easy for tracking and resolving any issues related to supplies. The depots shall be maintained with sufficient quantity of IP’s throughout the study to meet the requirements at the site. A line of authorization is built in while shipping the supplies to sites as not all sites require the supplies as generated by the settings provided for the system. This line authorization shall check and cross verify the requirements with site and approve the shipment. This level shall not allow the overflow of supplies to sites when there is no such requirement. There shall always exist the physical shipment of supplies from the sites with overstock to the site having low stock. This physical shipment shall be tracked in the system with a functionality called ‘Return to Depot’ where the sites with overstock shall return the supplies to Depot and the shipment shall be generated from the site with low stock. This feature helps to manage the supplies without any further demand in the production.
  • An Eagle Eye – Audit Trail: It is mandatory for a trial personal to know each and every aspect of the study regarding the activities of site, depot, kit, users. This will always help the administration team to view the status of the study and monitor the pros and cons during the study conduction. The audit trail is designed in such a way that an administration team can filter and know the activities by user wise, site-wise, depot wise, and the status and history of kits as well.
  • Data Visualization through Dashboards and Reports: There shall be many factors to be focused on throughout the conduction of the study. These parameters shall be monitored easily when their status is displayed on the dashboard and the data is projected in the form of reports. The pending visits of a subject can enable the administrator to plan the resource and check the supplies at site. The summary of orders on dashboard also helps the trial team to track the supplies. The reports should be developed in such a way that it gives the complete overview of the study in terms of the sites, depots, kits, visits, etc. It should be easily accessible and user-readable. The events and alerts shall be shared with the desired team as on when required in the form of notifications and are one of the other best ways to inform the status of the study being conducted. IRT is recognized as the realistic data provider so that it can be integrated with other tools like EDC and CTMS as a source data provider. The evolution of IRT is not defined to a certain point, as the designs of the studies increase the evolution and the facets of IRT also increases.

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