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Applied Clinical Trials November 2022

Ukraine invasion tests the resiliency and quick action of CROs and sponsors

Mobilizing and Maintaining Clinical Trials in Midst of War

ACT's biennial Salary Survey takes a look at the future of industry following increased adaptation of decentralized technology 

Salary Survey: The Age of COVID

Cytel has entered into an agreement to acquire SDS Life Science AB and SDS MedteQ AB. The move will add new global talent to Cytel’s Strategic Consulting group and bring additional capabilities for the strategic development of drugs and medical devices.

Articles

Move will add new global talent to Cytel’s Strategic Consulting group.

Cytel Acquires SDS Life Science and SDS MedteQ

OneStudyTeam and Antidote Technologies announced a partnership to provide sites and sponsors with a connected, patient referral management experience to give them control in clinical trial recruitment efforts.

Partnership to connect recruitment and enrollment systems.

OneStudyTeam and Antidote Announce Partnership

Director, Quality & Compliance, Diligent Health Solutions

Global Chief Operating Officer, Diligent Health Solutions

It is best practice for life sciences companies to audit their medical affairs (MA) functions at least every two years—whether those services are provided in-house or by a 3rd party vendor. Audit frequency is risk-based and typical industry standard for a vendor/supplier audit is 3-5 years. Regulations do not specify timeframes, only that an audit is required.

Prior to COVID-19, audits were mostly conducted in person. The pandemic forced companies to look for other ways to meet their audit obligations, and a virtual (remote) approach was generally seen as preferable to delaying the audit. When designed properly, companies found that virtual MA audits, conducted live, produced the same depth and breadth of observations as in-person audits. The virtual approach is now firmly established as a viable alternative, even with the easing of COVID restrictions.

There are some inherent challenges with virtual audits, most of which can be addressed during the planning process:

Establishing an effective auditor-auditee relationship.

 As at-home workers across the globe know, it is more difficult to establish working relationships via Teams or Zoom than it is when you can look someone in the eye and read their body language. While this is something to be aware of, auditor-auditee interactions by nature are collegial but not overly friendly and this is likely not a significant detriment.

The lack of physical proximity requires additional planning. 

If there is more than one auditor, it is likely they are not in the same location. The same is true for those being audited. Communication channels, such as a group chat, need to be set up for private “sidebar” conversations (between auditors; between auditees) during the audit. Additionally, a separate Teams or Zoom meeting should be set up by each entity to converse during audit downtimes.

The start and stop nature of the auditor-auditee communication. 

As with an in-person audit, an auditor will want time alone to review documents. This means that allparticipants will log in and out of the Teams or Zoom meeting multiple times. A way for the auditor to notify all participants that it’s time to return (e.g.; a group text) should be set up.

 An IT person from each organization should be on standby in case addressable issues occur. On a related note, at-home audit participants should be encouraged to set up their smartphone as a mobile hotspot in case of an internet outage.

Planning is key to a successful virtual audit:

The objective of any audit is to collect documented evidence that the auditee is following established procedures and is in compliance with all applicable regulations. Possible elements of a Medical Affairs audit include the handling of Medical Information inquiries, Medical Science Liaisons procedures, and the documentation and reporting of Adverse Events and Product Complaints.

Identify primary contacts (auditor and auditee). 

These are the people who will maintain communication through all stages of the audit. (It is essential that participants on the auditee side are deeply knowledgeable of the processes being audited.)

Create an audit plan to send to the main auditee contact. 

Start and end times (taking time zones into consideration)

Company began audited (if services are provided by a 3rd party vendor)

Name, title, and contact information of the lead auditor (and co-auditor if applicable)

Name, title, and contact information for the main contact (and other audit participants as provided by the main contact)

Outline and timing of audit prep activities, including documents requested in advance of the audit

Outline and timing of post audit activities (the audit report; the response by the auditee)

Test platforms and communication channels that will be used in the audit.

 This is best done two or more weeks prior to the audit start date.

Share expectations of the role and guidelines for effective audit notes.

With both in-person and virtual audits, the requested documents are typically shared in a PDF format through a private secured network. If the audit is of a 3rd party vendor, the auditor’s access is read-only (no printing or downloading of documents) and is only for a limited time. This approach is convenient for the auditor, allows the auditee to control access, and is environmentally friendly.

Permanent storage of documents should be in a private, secured, and validated repository that utilizes file indexing and OCR (Optical Character Recognition) for the easy retrieval of documents.

The most notable advantage of virtual audits is that they save time and money. Conducting an audit virtually eliminates travel expenses and reduces the time auditors need to devote to the audit activities.

Even though audits can be effectively performed virtually, in-person audits are not a thing of the past. If the services are being provided in a location geographically close to the auditor, an on-site audit eliminates the challenges associated with virtual audits. A hybrid approach can also be taken—in which the bulk of the auditor’s document review takes place remotely, and a site meeting is held for questions and answers.

, global chief operating officer; both with Diligent Health Solutions

Virtual audits proving to be beneficial post-COVID despite continuing challenges.

Virtual Medical Affairs Audits: A Viable Alternative

Calyx announced an enhancement to its interactive response technology (IRT) system. By removing the supply monitoring burden from clinical trial teams, Calyx IRT's automated supply strategy management reduces the cost of drug waste while ensuring the study drug is available at investigative sites on time.

Intelligent functionality removes supply team burdens while ensuring drug availability and reducing waste.

Calyx Enhances IRT System

https://informaconnect.com/clinical-trials-europe/

Events

Clinical Trials Europe —11/7-11/9

Inato has announced its latest platform enhancements. The enhancements will help community research sites offer more clinical trials in their communities by streamlining trial matching with pharma sponsors and reducing redundancies in the trial enrollment process.

Enhancements will help community research sites offer more clinical trials by streamlining trial matching with pharma sponsors.

Inato Announces Platform Enhancements

Precision for Medicine announced the culmination of its Next Generation Sequencing (NGS) initiative which improved the accuracy and speed of identifying cancer mutations in solid tumors, allowing researchers and manufacturers to develop patient-specific diagnostics for improved clinical outcomes.

Next Generation Sequencing (NGS) initiative improved the accuracy and speed of identifying cancer mutations in solid tumors.

Precision for Medicine Announces Culmination of Next Generation Sequencing Initiative

Medable announced the availability of its Total Consent offering, a fully enabled SaaS electronic consent management solution compatible with clinical trials in more than 120 locales around the globe.

Total Consent offering is an SaaS electronic consent management solution compatible with clinical trials in over 120 locales worldwide.

Medable Announces Availability of New eConsent Platform

medmix Drug Delivery (Haselmeier) and AARDEX Group announced a collaboration, combining Haselmeier´s D-Flex™ Logbook with AARDEX Group’s Medication Adherence software and hardware ecosystem.

Haselmeier developed the D-Flex Logbook, a wireless connected drug delivery solution. Now this solution can be integrated into AARDEX Group’s adherence software, MEMS AS®.

Combines Haselmeier´s D-Flex™ Logbook with AARDEX Group’s Medication Adherence software and hardware ecosystem.

AARDEX Group and medmix (Haselmeier) Announce Collaboration

Veeva announced a ten-year strategic partnership agreement with Merck that builds on the existing 12-year partnership between the companies. Under the terms of the agreement, Merck will select Veeva products when they are fit for purpose. Veeva will provide Merck with a strategic pricing approach and Merck will have input into Veeva's product roadmap.

Ten-year partnership will help Merck reduce operational costs and deliver value to patients, HCPs.

Featured Content

Applied Clinical Trials November 2022

Mobilizing and Maintaining Clinical Trials in Midst of War

Salary Survey: The Age of COVID