Power of transparency.

Agility Clinical needed to keep internal and external team members informed and on the same page.

Projecis. Done.

Agility Clinical is a fast growing consulting and contract research organization that works primarily with virtual-to-small biopharmaceutical and medical device companies that often specialize in rare disease and orphan drug development. They provide full clinical trial services from IND submission, orphan drug application, and , study design through regulatory submission for marketing approval. As an adopter of the latest technologies, they started using Projecis shortly after Agility Clinical launched in 2012.

“Projecis has really served us well as a tool that promotes communication, transparency and accountability.”

“We use Projecis on full scope projects to share the calendars and to monitor our staff in terms of scheduled time off, which really helps us manage our human resources. We can post minutes from a meeting and ask everyone who wasn’t there to read through them, comment on them, to make sure that the whole team stays informed and on the same page. The system also provides an excellent audit trail to ensure that team members and clients are staying on track with review schedules.”

All clinical trials involve a significant need for secure, controlled access to information. “We were one of Projecis’ early clients and they were very responsive to our growing needs. For example, they created a way for us to share Standard Operating Procedures with clients who wanted to review them, but in a way that wouldn’t allow them to be downloaded or printed. The Projecis team is incredibly responsive and created a solution that is flexible and adaptable to our needs.”

The feature-rich document sharing capabilities have become an essential part of Agility’s our project life cycle. “We use Projecis to give our clients access to documents for customized review periods with , specific date ranges, which is very helpful. We create a secure project ‘room’ within Projecis where we can share and collaborate with our clients. They can tell us what they want to see and we can pull it from the Trial Master File, upload it to Projecis, and share it from there. It’s convenient, protects the documents, and is accessible to the team members from any location with access to the internet. Projecis is very intuitive, allows for a clear file structure, and offers a robust search capability, which makes it very easy for clients and our internal team members to navigate through the project documentation.”

“Projecis is also an important part of our communication platform with our international clients based in Europe and/or Sub-Saharan Africa. Emailing large files across several internet access points is not safe or convenient. Additionally, the standard paper size in Europe and Africa is not the same as the US, so sending a hard-copy binder to a site in Africa or Europe would not only be expensive, but it just wouldn’t be practical for our sites or clients. Instead, we can upload the required documents into Projecis and then our team members can access and print them on their end. This kind of convenience and customer service lowered costs for our clients and created efficiencies.”

Agility specializes in orphan/rare disease research and often its clients have tight operating budgets. “Projecis is an affordable way for us to work together and support our clients without an expensive electronic TMF solution or Clinical Trial Management System (CTMS),” says Clark. “In addition, many of our study sites are spread out geographically, so for just a small fee, we can have Projecis seats for whoever needs to be involved. We have quite a few users, and Projecis has consistently been a dependable, easy-to-use tool to help us manage our projects, knowledge and resources.”

Success Stories

Positioned for the future.

La Jolla Country Day School needed a software system to revolutionize and secure their recruitment and admissions programs.

They turned to Projecis.

La Jolla Country Day School (LJCDS) is a premier educational institution in San Diego that has been dedicated to offering a wide diversity and depth of college preparatory academic, artistic and athletic programs for over 80 years. Historically, its entire admissions data and tracking system consisted of essentially one large spreadsheet. LJCDS needed a more sophisticated, streamlined tool.

“Projecis plays a critical supporting role in our ability to provide excellence to our clients.”

Projecis collaborative software was introduced to begin tracking actual student admission data for each enrollment year. In addition, Projecis Pro Services built a web-based dashboard for LJCDS to navigate and maintain all the historical and new information and report it in real time for qualitative analysis.

While managing enrollment at LJCDS involves data, metrics and reports, behind each data point is a unique child and family. Projecis’ extensive security and access control provided the protection LJCDS needed for its confidential, sensitive personal information.

In this private school setting, many scenarios repeat annually, such as application reviews, admissions, and grade level promotions. Projecis worked closely with LJCDS to better organize and automate its data collection and reporting so that its team members had more time to spend interpreting what the data meant for the success of their school and student body.

Inez Odom, the Director of Admissions, explains, “That shift from quantitative to qualitative data trend analysis was a huge leap from where we were before, and has really helped us turn a large amount of information into useful knowledge.”

Success Stories

Staying on the same page.

Spaulding Clinical Research looked for a way to manage, track and share the huge volume of information and tasks they value for success.

Projecis filled the bill.

As a clinical research facility, Spaulding is responsible for testing and research for both potential pharmaceuticals and medical devices. As such, they have a very structured clinical research environment that requires rigid protocols and regulatory compliance for their processes and procedures. And, of course, confidentiality and security are incredibly important to preserve the integrity of clinical trials.

“I don’t even like to think about what my job would look like without Projecis.”

Projecis took this very complicated system—involving many people, deadlines and tasks—and made it much simpler to manage efficiently. What used to be a mass of spreadsheets, faxes and phone calls—between team members as well as external client partners—is now a clean, centralized interactive process with instantaneous data-sharing and real time updates. As Heather Spears, Clinical Information Manager at Spaulding, puts it, “Fortunately for us, Projecis is easy to use, intuitive and flexible with multiple digital pathways that get you where you need to be.”

Recognizing the sheer volume of tasks involved in setting up a new clinical trial, Projecis worked with Spaulding to create templates for the three most common types of trials and studies, including certain milestones, tasks and durations that are specific to clinical research. Normally, creating a project from scratch would easily have taken a day and a half, but the new templates allowed Spaulding to get project timelines in place and specific tasks assigned to the right team members in less than an hour. On top of that, Projecis made it easy to customize the templates to specific projects that might have unusual requirements. Spaulding found the efficiency, productivity and quality-control benefits to be monumental.

Spaulding Clinical also found a huge benefit from using shareable Projecis features—like Gantt Charts—to show the status of tasks and their progression throughout the clinical trial. Clients can now view the progress of their project at anytime without waiting for reports from Spaulding.

Projecis’ ability to share visibility of timelines and deadlines also allows clients to manage internal schedules and resources in order to meet those deadlines and keep the project on schedule. Projecis facilitates transparent communication and sharing of information between both Spaulding team members and client stakeholders. As the project moves forward, changes are communicated immediately and Projecis helps the team navigate the changes with minimal delays in momentum.

As in many fields, in order for a clinical trial to be completed successfully, Spaulding must work in tight coordination with their client partners. The high visibility of data and of projects-in-progress creates a relationship of confidence and trust and accountability, fostering a strong partnership between Spaulding and its clients.

Success Stories

Simplifying the complicated.

Synergy Research Group wanted a powerful, flexible tool to help keep pace with their growth.

Projecis was the obvious choice.

Synergy, a rapidly growing clinical research organization headquartered in Moscow, Russia, was frustrated by ineffective email-based project management and chaotic document and information exchange.

“When meeting with a sponsor, now I don’t even take my notebook—all I need to make a company presentation, or drill down into a project’s details, is Internet access to Projecis.”

“Projecis was our obvious best choice,” says Synergy’s CEO Igor Stefanov. “What set it apart were things like the ability to maintain various project schedule baselines, security and confidentiality, temporary access for sponsors, partial task execution and status, document version control and tracking, a project discussion area and electronic signature. That’s a long list of features that weren’t even offered by the other systems we looked at and, when they did offer the features, the quality just didn’t meet the standard set by Projecis.”

“Projecis is so flexible and efficient that we use it well beyond project management. It is versatile enough to improve our efficiency in so many other areas of our operation; we also now use it for Standard Operating Procedure management, Human Resources and our Learning Management System.”

Projecis has also changed Synergy’s RFP (Request For Proposal) process. They work together to prepare the proposal using Synergy’s standard form, which is then uploaded into Projecis where it can be modified with clearly tracked versions, discussed in the comment area, and linked to supporting documents and knowledge, such as teleconferences with the sponsor.

“I have access to everything I need 24 hours a day, 7 days a week from any place in the world. No VPN, no IT headache. Client and prospects are really impressed with this comprehensive, cloud-based technology and it adds to our reputation for efficiency and sophistication.” I’m happy to have the Projecis team of experts on board with Synergy — they’re not just software providers, they are real partners.”

Success Stories