LifeScience

What is a "higher performer" in this case?

Probably worth saying that higher performers were those that said they were delivering well in areas such as productivity, innovation, employee satisfaction, management of risks/costs, etc

We had 8 indicators in total (see the report for more details)

While the higher performers do look better especially in the "generally very poorly" section, there is still opportunity to improve further. As these projects are truly representing #digitaltransformation , time and change management are key to success.

The achievements made by this group shows specific focus in the areas that we have discussed before: Information Access and Collaboration.

But even for the rest of the companies it is not too late to start these projects and learn from the solutions & experience that is already available

Yes, organisations might be 'managing', but even the higher performers could do a lot better.

the problem is that people get used to sub-optimal systems

In many ways we made people think - maybe sometimes for the first time - when we asked them such specific questions in this study

I wonder if the starting point should be raise expectations - aim higher(?)

Oh wow, very few say their current systems are performing very well...

What strikes me here are the difficulties to access (the right) information and to have it available during the complete process.

Quite shocking really. I guess, with the information needs and volume changing so fast, older systems can't keep up??

Historically most organizations established (at least) two major repositories: One for regulated and one for non-regulated content.  But as content can become GxP-relevant at one point in time of its' lifecycle, a copy is made to an other system - which causes confusion over time

Also the integrations in other systems holds major room for improvement.  In times where best-of-breed solutions can be easily adopted even by smaller teams within the organization, it is critical to avoid that every one of these is creating a new content silo of its' own.

I think the main issue is that when systems are limited, things still get done, but more not very efficiently, and with a high degree of cost, risk and distraction.

Providing one foundation for ALL content types, effortless permission controls and embedded collaboration features can takle a wide portion of these issues.

How bad is the #collaboration gap?  What does it mean for specific teams (#Research #clinicaltrials)?

We were clearly picking up a lot of frustration with systems

This impacts the individual, internal team collaboration, and collaboration between teams (including external)

Looking at the pink and yellow bars, I would say that there is a big opportunity for many #lifesciences organizations to improve in a way that really benefits the workforce.

If we look at the clinical domain as an example: If a sponsor company is conducting a Site Selection and Site Feasibility Analysis for a large Phase-III test, often times hundreds of CROs need to be evaluated and sensitive information has to be disclosed.

Yes, it would avoid experts getting bogged down in low value activity.

For many companies, this is still a very manual process that can "entertain" a dozen people in the ClinOps team for weeks. As most information is captured manually and needs to be transferred to other, not integrated systems, errors occur.

On a specific point, I really don't think we should underestimate the implications of poor workflow.

Providing a solution that helps the internal staff to identify the right set of information quickly, securely share it with all CROs simultaneously, keep track of the progress and integrate the provided responses directly the system used for decision making can free-up value

expert time, cut the required time dramatically and increase the overall data quality.

Modern systems can make sure information flows to the right people in the right way at the right time.

Why is this significant?

Research staff working in a Life Sciences arguably exhibit one of the most complex and demanding set of needs in the end user computing space.

They deal with lots of different data types and sources, which may or may not be regulated and/or commercially sensitive. At the same time, need to collaborate extensively both internally and externally.

(edited)

Collecting information in an auditable fashion has been around for decades and a lot has been accomplished so the times where truckloads full of paper were sent to the regulators are over (well,
in most places).

Global collaboration is fantastic, especially in speeding up #clinicaltrials, but not without its difficulties. Security and competition are issues, correct?

With changing markets and increased externalization (research activities, joint ventures, M&A, outsourcing of clinical trials, etc.) the requirements to provide seamless access to information across different (global) departments and 3rd parties increased dramatically.

But the security and protection controls still need to be applied. If systems don't support these end-to-end processes in a secure manner, users have challenges to complete their daily tasks.

I think the key word here is 'seamless'

Do grown IT-Infrastructures potentially limit the ability to adapt to all those requirements?

Sieglinde: That is what we are seeing and what has also been confirmed by the study. We will get to some additional details soon.

There's always been collaboration between institutions, but it's now much faster-moving and involves a lot more data. Older systems and processes often don't support that well. Email attachments then become the fallback in too many cases.

A key stat for me is 48% of Life Sciences respondents in the study described collaboration-related demands as “High and Growing”. This is much greater than in other regulated industries.

Nearly two-thirds flagged up a ‘high’ need to share sensitive information with clients, suppliers, contractors, etc.

The risks of making mistakes when sending documents and data around, e.g. when relying on email attachments springs to mind.

I know here in the UK, the NHS still is not 100% digitised. So much data is on paper and they are trying to digitise it. The sheer amount of data in #lifescience #pharma and #health is a challenge. I see #workflow come up in the results.

The most significant challenge is #workflow, according to the study.

If systems were better in this area (workflow), particularly if routing and policy could be embedded in an intelligent way (AI anyone 😊), it would also take some of the pressure off employees.

Nearly 70% in the study, for example, talked about the ‘Responsibility burden’. With so much information subject to so many different controls flying around, the view is the systems often don’t help.

The study was sponsored by @Box and @Medidata, and conducted by@freeformcentral in collaboration with @TheRegister.

Views were gathered from 127 respondents via an online survey. Approximately half of the respondents were from the life sciences industry, with the remainder drawn from other highly regulated sectors.

The sample was global but weighted towards North America and the UK, with a range of organization sizes represented.

What job leel did you interview?

The participants were a really good mix - some senior, some practitioner level - involved in both solution delivery and the use of systems. Gave us a pretty rounded view.

Since the study was hosted by @TheRegister, a lot of people would have seen it. When was it done?

What was interesting was that there was a lot of consistency in the responses, i.e. the there seemed to be a consensus on the requirements, challenges, etc

For those who haven't seen the report in full, you can download it here: https://www.box.com/en-gb/resources/db-medidata-li... But do follow along now, as we discuss the results

Interesting that the challenges and requirements are similar across different countries.

What would you call the most interesting finding out of this report?

Yes

@baerlinizer We get to that in a minute. :) :)

Life Sciences organisations deal with regulated data and apply strict controls to comply with privacy and GxP regulations, especially in R&D, yet information sharing and collaboration are key to innovation.

One of the main things we wanted to get from the study was insights into how highly-regulated companies are dealing with key digital and information-related trends.

A big question we had was how the proliferation of electronic information sources, and evolving needs and expectations of users around access, sharing, etc, sit with the ongoing requirement to manage risk and compliance.

We recruited participants from a spectrum of regulated industries, but put a focus on #LifeSciences as the sharing of data between institutions to support collaborative research and innovation added an important additional dimension.