The Concinnity Company

Ever wonder what fuels the success of a clinical trial? It boils down to collaboration—bringing together diverse teams of sponsors and Contract Research Organizations (CROs), often spanning multiple geographies. Sponsors take the lead by setting the course, securing funding, and ensuring that every regulatory requirement is met. They are responsible for designing the trial protocol, selecting sites, and making critical decisions to keep the trial on track.

For starters, much of the technology needed for personalized medicine is still nascent compared to other areas of healthcare delivery. The big data analytics required to reliably interpret patient DNA or genomics data is not yet readily available at all sites conducting research. In addition, sites that have access to this type of technology require highly specialized personnel – including genetic counselors, bioinformaticians, and biostatisticians– who are in high demand across many industries.

The Cloud Concinnity platform was built to meet the specific needs of clinical trial managers, CROs, and DSMBs. Our cloud-based system provides trial stakeholders with a centralized platform for patient information, communications, processes, and reporting onto a single, secure hub to improve their quality of life.

Improving data protection begins with creating a comprehensive data protection policy.

The policy can be as detailed or straightforward as your organization deems necessary. It should include:

• A description of the measures taken to protect data.
• An outline of the responsibilities of each party involved in the data collection process.
• A list of the types of data that need to be protected.
• Procedures for monitoring and responding to any potential security breaches.

Cloud Concinnity was specifically built to meet the need for more efficient, effective clinical trial management. Our cloud-based integrated platform centralizes, simplifies, and automates control of data, communications, process management & reporting while unlocking the value of big data.

Traditionally CROs have offered full-service outsourcing (FSO) models to pharmaceutical and biotechnology companies to support clinical trial operations. However, a significant shift toward functional service provider (FSP) models has been gaining traction. This shift is not just a trend; it’s becoming the new norm. The top 10 pharmaceutical companies have adopted FSP models, and nearly half of the companies ranked 11th to 20th are using a combination of FSP and FSO models.

• 95% of cybersecurity breaches are caused by human error.
• The U.S. was the target of 46 percent of cyberattacks in 2020, more than double any other country.
• Data breaches exposed 22 billion records in 2021.
• In 2021, nearly 40 percent of breaches featured phishing, around 11 percent involved malware, and about 22 percent involved hacking.
• The top malicious email attachment types are .doc and .dot, which make up 37 percent; the next highest is .exe at 19.5 percent.

The COVID-19 crisis has pushed us all to adapt and work smarter than ever. Virtual meetings and remote work are the new normal, and that includes virtual board meetings that require trustworthy remote working software. As a company who built our board management and GRC software around best practices cemented in our collective 100+ years of board and c-suite experience, we offer our team’s best practices for your virtual top of house meetings.

Best Practices for Leading and Governing Virtually. When chaos is the new normal, Cloud Concinnity® delivers board management software and GRC tools so you have the freedom to think.

Cloud Concinnity® is smart software built to manage exactly the kind of crisis happening right now, based on our founding team’s 100+ years of top of house experience.

Automation in clinical trials can improve efficiency and accuracy, leading to more reliable data and quicker trial completion. It can also reduce human error and save time and resources. Implementing automation technologies can streamline data collection, analysis, and reporting processes, allowing for smoother trial operations.

Additionally, automation can help ensure compliance with regulatory guidelines and reduce the risk of noncompliance issues.

Virtual clinical trials require efficient and secure methods for remote site oversight and monitoring. This includes virtual visits, remote source data verification, and virtual document management.
When building your virtual trial tech stack, it’s critical that you include a system that can manage each of these core needs. As a best practice, ensure you choose a system that is:

• Easy-to-use.
• Effective at meeting your core oversight and monitoring needs.
• Bug-free (or as close as you can get).

The Concinnity Company has announced the release of Cloud ConcinnityⓇ 3.3.0. Cloud Concinnity is an integrated process management platform for clinical trial oversight. Concinnity was recently named a Top Ten eClinical Trial Management Solution Provider.

Clinical trial sponsors and clinical research organizations (CROs) manage dozens of ongoing clinical studies simultaneously throughout the year.

Cloud Concininty’s 3.3.0 release further enhances our meeting scheduling functionality. It is designed specifically for scheduling meetings among sponsors, committee members and other required parties. Selection of available times are now even easier to select from calendar views. And we’ve solved a time zone issue for teams with users in several different time zones.

• Try flipping the script on board meetings. Spend just 20% of the time presenting information, and 80% on discussion.
• Choose a facilitator to keep everyone moving through the agenda and keep momentum going as needed.
• Set an agenda and clearly define the objective of the meeting. Share it beforehand.
• Keep meetings short and sweet. If there are multiple topics to discuss, consider breaking one meeting into short, smaller meetings with specific outcomes goals.

• Depending on the formality of your role, consider investing in a good camera. This could likely be an upgrade from what comes with your laptop.
• Develop work attire rules with your working group. Agree on what level of casual is appropriate, and reserve the right to not show yourself if you can't meet the agreed upon standard.
• Elevate your laptop/camera so people aren't looking up your nose.
• Mute yourself when you’re not speaking, but get agile at unmuting yourself.

• Use Great Software: Make sure your team has a fulsome cloud based, secure platform to share information in advance of meetings. Demo Cloud Concinnity® to see why it beats everything else hands down.
  
• Create a dedicated space in your home for virtual meetings. Tailor that space to be a clean, simple background for your screen.
• Depending on your company’s policies, consider installing a video conference add-on to your calendar to seamlessly schedule, join, and manage meetings.

• Create time for exercise. Staying mentally sharp is directly related to movement.
• Eat healthy food. What we put in our bodies has a direct affect on how alert and aware we are.
• Get enough sleep. The sleep we get sets the stage and the tone for everything we do.
• Charge your devices overnight. Don’t be fumbling for the cord during a meeting or have your computer cut out mid-thought.

Anyone watching Silicon Valley companies lately knows that every disruptive breakthrough that redefines a market can turn around and disrupt their own growth if no one is paying attention.
Uber’s absentee board for much of Kalanick’s tenure is one example. The litany of privacy concerns and questions now plaguing Facebook is another.
Indeed, the things that make tech entrepreneurs great at disrupting industries can also plant legal landmines if no one on the inside is watching their back.

It’s the board’s responsibility to make sure that the glad-handing and bluster that plays well with the camera is backed up by legally sound paperwork and best practices. Founders aren’t supposed to know all of that stuff – the board is. And it’s the board’s responsibility to speak up, not get swept up. Uber could have saved itself a lot of bad press and a year of backsliding if they had taken action early on Kalanick, or even seen it coming and stepped in long before it became an issue in the media.

Not long ago I heard a story at a board colleague’s retirement dinner that made me smile

At the retirement dinner in late 1984 the staffs of both the National League of Women Voters and the National Football League were busy going about their respective businesses. Unbeknownst to them, their worlds were about to collide.

EFFECTIVE CORPORATE GOVERNANCE IS A HALLMARK OF ANY HIGH-PERFORMING BOARD AND EXECUTIVE TEAM.
We believe that governance and leadership are the most important ingredients for high-performing organizations, and of course governance is half the battle, although often overlooked.

The League was hard at work getting agreement between the campaign staffs of Walter Mondale and Ronald Reagan on the particulars of the fall presidential debates, something which, I understand, is about as easy as negotiating a major trade agreement. At long last the dates were settled and the staff went about the process of notifying the media. Almost immediately the president of the League of Women Voters received a phone call from a senior executive with ABC television.

Below are the ten most common corporate governance mistakes we typically see:

• Failure to clarify roles and responsibilities between the CEO/C-suite and the board.
• Failure to get the right people around the boardroom table, fully engaged, and doing the right things.
• Failure to develop consensus in detail about where you are, where you are going, and how you will get there.
• Failure to tend carefully to the interests of multiple, diverse stakeholders.

SUPPORTING YOUR GROWING PORTFOLIO IS MISSION CRITICAL. WE MAKE IT EASY TO IMPLEMENT and REINFORCE BEST PRACTICES & YOUR PLAYBOOK FROM DAY ONE. AFTER ALL, SUCCESS IS A HABIT BUILT ONE INTERACTION AT A TIME.

Take the pulse of all your portfolio boards on one platform, with all key information, communications and metrics at your fingertips. With each company’s dashboard and intelligence scorecards in one place, you have simplified visibility and a chance to identify early warning indicators. Secure, consistent, and available anytime, anywhere.