Reputation and Integrity Remain Critical in Clinical Research
A contract research organization (CRO) is only as good as its reputation. Paragon Biomedical has been successfully conducting clinical research in drug and device development for over 20 years. At Paragon Biomedical, we have long been recognized as having a reputation for conducting high quality clinical trials with a focus on project delivery. We are extremely proud of the reputation we have built that has no doubt resulted in long-lasting relationships and higher loyalty and trust from our employees. This has led to a high repeat business rate and low project team turnover. Integrity through accountability and solution minded thinking is what Paragon has built over the years and continues to today.
A company’s overall reputation is framed by various perceptions and experiences in the clinical research industry. When evaluating CROs and vendor organizations, Sponsors may make their selections based on a variety of questions including: What is the quality of the organization’s services? What experiences do others have with the CRO or with the project manager? Is the relationship between price and quality good in terms of overall value? Does the CRO know the therapeutic area, the indication, the regulatory environment, the investigators?
Building a good reputation requires effort, patience, good honest intent, and time. Destroying a good reputation only requires a single misstep, even if accidental. A reputation is a fragile thing and it requires consistency and care. A good reputation provides us with a target at which to keep aiming. We must constantly work with one another internally and externally to achieve the high marks Paragon has been accustomed to. Each project team member at Paragon plays an active role to ensure sponsor requirements and regulatory guidelines are being met at all times. Whether you are an executive, a project manager, a CRA, work in IT, finance, site management, data management, or any other functional area, we are all part of earning a great reputation and achieving the highest integrity. Both reputation and integrity have become the real differentiators in drug and device development and clinical research, and at Paragon, we let them serve as motivation for continuous improvement.
If you are looking for an honest flexible CRO with integrity and an outstanding reputation, call Paragon Biomedical at 949-224-2800 or visit us at http://www.paragonbiomedical.com
Project Timelines Can Be Achieved With the Right Planning
During a project’s formative stages, the amount of time needed to accomplish the project’s goal may seem sufficient, even plentiful. It does not matter what the project is–home improvement, organizing a fundraiser for a charitable organization, or conducting a clinical trial. However, as a project begins to take shape and interest grows, others become involved and there are often pressures to do everything faster.
As a project leader, you need to manage all of the “moving parts” and know how they come together, but you may quickly find yourself asking “Is this even possible?” For successful timeline management, begin by answering the following questions:
1. What is the ultimate project goal? It is important to answer this question succinctly and without embellishment. A clearly defined goal will support the decision-making process and vigilance against “scope creep”.
2. Who are the key stakeholders and what is/are the business drivers related to project completion? Ensuring all involved parties are in agreement with the goal and the desired outcome will facilitate teamwork and communication throughout the life of the project.
3. What are the tasks that need to be completed to accomplish the goal? A fully defined task list with the appropriate level of detail is an absolute requirement. When there are several functional areas involved with the project, each area needs to understand their own tasks and how these tasks contribute to the overall project goal.
4. What are the standard benchmarks for each task and which tasks are dependent upon the completion of other tasks? Which tasks can be done in parallel and which tasks can only be done sequentially? Which tasks may benefit from additional manpower and which ones would be hindered? The answers are important not only within a functional area, but are equally important for tasks that involve handoffs from one group to another. Understanding the requirements and demands of both upstream and downstream tasks will facilitate smooth transitions and the development of an accurate project timeline.
5. Are there technology solutions that can positively impact the project? Are the technology solutions viable and more than an industry “buzz”? What’s the ROI (return on investment) and will they really save me time and money? Utilizing a tool like Microsoft® Project or BrightWork® to manage the overall project timeline is extremely helpful and can bring the CRO and Sponsor closer together with common goals. CTMS (clinical trial management systems) can work much the same way to drive internal metrics or track important project details. In addition, industry experts estimate that >80% of all new trials (Phase I – III) have an Electronic Data Capture (EDC) component for their clinical trials. These figures are likely to continue increasing as technology becomes refined and more cost competitive. In the end technology can be a GREAT tool if evaluated carefully to meet your needs and used with corporately aligned end goals in mind.
Today’s turbulent market makes it imperative to deliver the expected project results, on time and on/under budget.
With the above information, a project leader can develop and maintain an understandable, accountable timeline that keeps all parties focused on the prize—the project goal.
Paragon Biomedical is a global, full-service clinical research organization (CRO) providing Phase I through IV clinical research services and support to the world’s biopharmaceutical and medical device companies. Paragon is a certified woman-owned business.
By Marianne Plaunt, Ph.D. Vice President, Global Project Services
More about: Global Clinical Trials along with Customized Technology and Resourcing Solutions
Visit Paragon Biomedical at www.parabio.com
Emergency Room Chaos: How’d they make me better?!
Walking into an Emergency Room you see all types of machines in use, but it is the smooth teamwork and each team member’s ability to handle the patient, the issue, and the technology that creates successful outcomes. Study start-up can feel a bit like an emergency room with different pressures, timelines, and study changes occurring on a moment-to-moment basis.
“Good” study start-up sets the stage for successful study conduct and staying within budget. But what does “good” entail? Terms like quick, rapid and fast study start-up are all used with the end-result expected to be beating the timeline. However named, this type of start-up does not mean a study will beat timelines. Often, these start-ups are fraught with poor site selection, re-work, and confusion, which ultimately cost money by delaying study close-out.
Like a top-notch Emergency Room (ER), study start-up must include the vested interest of all shareholders (CRO, sponsor, site, IRB, vendor, etc.) and must include an organized, staffed, educated, and planned implementation. I could focus this blog on hugely helpful “things” that aid study start-up, like slick systems or smart-forms or portals. But, start-up cannot be successful if the people involved in the work are not contributing to the process in their fullest. Systems should be transparent, easy-to-use, and facilitate the contributions of the individuals.
1. Ensure the vested interest of the team: From the initial selection of shareholders, gather their true interest in the study. When you speak with them, are you having to find time in their schedule to fit-in your study; are you having to re-explain the procedures or purposes; are you the only one coming to the table with critical thoughts? All of these give you an idea of how interested and how much time they have to contribute to your study. Do not just count on industry reputation or checking a few boxes to ensure someone looks good on paper. Begin a relationship and foster collaboration.
2. Plan for organized delivery of start-up materials: Pressed for time and resources, and with a desire to bring people on-board at the earliest possible stage, many studies get started before clear plans have been developed. Multiple people work on the same process and process gaps form. Establish a plan, assign tasks and timelines, and encourage communication. To ensure you have a solid set of organized start-up materials, know what you need to get started – a final protocol, an IND/IDE number, a budget – and try to clear the “noise” of all the other complicating factors. Take an extra minute, hour, or day to be certain a document or decision is truly final, eliminating the re-work spawned by “get it out the door today” rushes.
3. Review resource availability: Sufficient staff must be present to ensure all tasks have an owner and volume can be met. A site might have the world’s best project coordinator, but if the coordinator has multiple timelines from several studies at various stages, s/he will be unable to focus on the critical deliverables for your study. In addition to volume, overlapping timelines can create an impossible situation for a quality deliverable. To secure sufficient resources, look at the resources available including those of the project coordinator, the tasks required, the volume of the tasks, and the timelines.
4. Develop an understanding your study: Each shareholder must take the time (repeatedly) to develop a clear understanding of your study both internally and externally. Sometimes this requires looking at the big picture, i.e., the primary outcomes of the protocol, and sometimes it requires looking at the microscopic view, i.e., the timing of specific-sample collection. However, this understanding always requires a balance between the two views and continued follow-up. Also, reminding shareholders of critical study components keeps the team focused.
5. Start with the end in mind: No start-up is “good” without requiring the entire team to not just “start-up” as a goal in itself, but to start-up with the long-term picture in mind. Ensure everyone is aware of what data is needed and deliverable formats, so the set-up can be utilized throughout the project, minimizing re-work in the end. Studies evolve, and better, prettier reports or spreadsheets become available, but if a format has been established keep it consistent and simple. Mid-stream changes create bottle-necks down the road. A day is a dollar (or $1M in our industry), but if that day spent in start-up creates a thoughtful plan which will eliminate many days during close-out, the time (and money) is well spent.
“Good” start-up requires communication – and effective communication comes from planning, educating, and investing the team at the outset. Like an effective ER team, use intuitive, quality systems to support the communication of a well-orchestrated team and your start-up will be “effective”.
By Tenley Koepnick, Director of Global Site Management Services
Visit Paragon Biomedical at www.parabio.com
Paragon Biomedical Understands the Unique Differences Between Medical Device and Drug Development
Paragon Biomedical is committed to successful project delivery in both medical device and drug development. Over the past 21 years, Paragon has successfully completed projects with >50% of the world’s Top 20 Pharma and Top 10 Device companies, and many large and virtual Biotechnology companies.
Before marketing most lower-risk medical products like some catheters or diagnostic imaging devices, manufacturers must provide the U.S. Food and Drug Administration (FDA) with a pre-market notification submission known as the 510(k), the most common path to market for medical devices. In general, the 510(k) must demonstrate a proposed product is substantially equivalent to another legally marketed medical device that is also lower-risk.
In September 2009, the FDA Center for Devices and Radiological Health (CDRH) set up two internal working groups, Industry and Consumers/Healthcare, to address concerns relating to the pre-market notification process. As a result, 55 recommendations were released in August 2010. In January 2011, the FDA unveiled a plan containing 25 actions which it intends to implement in 2011 to improve the 510(k) process. These actions, to be discussed over the course of the year, will make the 510(k) program a blueprint for smarter medical device oversight; one that drives innovation and brings important technologies to patients.
As the medical device industry changes and continues to grow, Paragon Biomedical will continue to be an industry-leading service provider focused on project delivery and customized outsourcing solutions for our Sponsors.
Let the experts at Paragon Biomedical help you plan and conduct your next study. Call 949-224-2800 to schedule a meeting or visit our website at www.paragonbiomedical.com
Global Project Delivery is the REAL Differentiator Between CROs
Today’s economic climate heightens the need for Sponsors to protect their research investment, making quantifiable measurement of CRO project team performance critical to success. The most effective way to protect Sponsor interests is through partnership with like-minded, quality-oriented suppliers committed to improving delivery and timeliness, and as a result, profitability. Paragon believes managing by metrics is a key component to the successful execution of each project.
Though measurement-based management was established in the post-World War II manufacturing sector, metrics can serve as a highly effective means of measuring and managing clinical trial performance; for individuals, teams, and organizations alike. Measurements surrounding staff turnover, timeliness of deliverables, quality of process and data, and client satisfaction are of prime importance.
Paragon uses a combination of systems, tools, and strategies to proactively manage timelines, identify potential hurdles, and develop effective mitigation plans. Paragon manages each project’s critical path, tracks project performance, and escalates any project issues. One of our tools for project enrollment analyzes potential scenarios to ensure project enrollment is completed on time.
Paragon manages project risk through a formal risk mitigation strategy. Project metrics, timelines, fiscal health, and any issues are reviewed by members of our Executive Management Team at Monthly Project Review (MPR) meetings. Any issues and/or trends identified during the MPR are escalated to the Project Performance Team (PPT) for cross-functional analysis and systemic resolution. The PPT team consists of corporate and operational leadership.
The combination of our focus on metrics, the use of proactive management systems and tools, and a formal risk mitigation strategy allows Paragon to successfully complete projects on or ahead of schedule. Our ability to customize data fields and provide our Sponsors with the metrics important to them is key to building long-lasting relationships, and has earned Paragon one of the highest repeat business rates in the industry.
Visit www.paragonbiomedical.com to learn more.
YES, A SITE CONTRACTING PROCESS THAT WORKS!
Why has Paragon Biomedical been so successful with the investigative site contracting process? Because Paragon has been proactive in making sure its investigative site contracting process is the best in the industry.
Streamlined reviews are the key to our success and our satisfied sponsor base. We use dedicated attorneys, not paralegal or administrative personnel like most CROs use, to support the site contract negotiation process. Paragon’s site contract templates have been carefully designed with input from small and large biopharmaceutical and device companies and from our years of experience in working with sites, and have been successfully used in numerous clinical trials. In addition, our fill-in-the blank confidentiality agreement can be populated, signed and returned by a site all in the same day. This step saves our sponsors 3 to 4 days in getting important clinical trial information to a site and results in faster feasibility and start-up activities. Also, sponsors say Paragon’s customizable CSA/budget tracker provides them with up-to-date contract status and metrics that demonstrate the quality and speed with which their site contracts are finalized.
We also recognize the critical role our investigative sites play. Their feedback is vital to the overall process and has been warmly welcomed at Paragon. Surveys and feedback from our investigators and site coordinators tell us our ability to sign and send a site contract to a site on the same day results in faster site initiation. Both sites and sponsors agree that assigning a dedicated site management services associate to each study ensures aggressive CSA/budget follow-up which speeds up negotiations and contract signing.
Paragon’s streamlined site contracting process has also been utilized to successfully implement and complete functional sourcing and stand alone project work.
The successful foundation for Paragon’s investigative site contracting process has been built from proactive planning and communication, with both our sponsors and our investigative sites, and in conjunction with dedicated professional resources to reduce the number of contract reviews needed to quickly finalize investigative site contracts. Site contracting is a critical step in study start-up activities. Does your CRO effectively handle the site contracting process? Paragon does.
Visit www.paragonbiomedical.com to request additional information.
Paragon Biomedical: Quality Culture in a CRO
When Gena and I started Paragon Biomedical over twenty years ago, we introduced several innovations to the industry including the now popular and welcomed decentralized service model, allowing PMs and CRAs to work from their home offices. From the very beginning, the model has allowed Paragon to deliver high quality work while accessing the best industry talent all over the world. We were asked back then, “What is the technology that makes these virtual offices so successful?” We had to admit that our “technology” was telephones (with answering machines) and faxes – that’s it. The “secret to our success” was not technology back then but Paragon’s “culture.” We established, from the beginning an expectation that the Project Manager was empowered (responsible) to respond to customer needs on their own within our internal requirements for openness, integrity and high quality. “Technology” as it was introduced, was welcomed as an aid to doing what we do more efficiently.
Today, while our “technology” is different and much more sophisticated and focused on customized sponsor solutions, our commitment to culture and people remain the same as the day Paragon started. Today we have a global technology backbone that securely and reliably moves data, images, video and voices around the world on a standardized IT infrastructure. The obvious benefit has been improved communication amongst employees, research sites and sponsors with real time access to vital clinical research information and data. Paragon will continue the implementation of the best new industry leading technologies without compromising our quality culture.
Learn more about Paragon Biomedical at www.paragonbiomedical.com
Nick Reed, Founder
The Days of the Checkbox CRO Are Over
Clinical research organizations (CROs) must rediscover their commitment to create the Phase I-IV clinical study solutions that will help pharmaceutical, biotechnology, and medical device companies (Sponsors) continue the momentum they have created over the past 18 months.
Sponsor gains have been hard-fought. And now – more than ever – CROs must step up and make the commitment to create flexible, responsive solutions that help Sponsors maximize their research investments.
We wrote last September in ParaBioPlus about choosing the right CRO for your company. In that posting,we suggested that CROs providing Phase I-IV clinical trial services can be roughly divided into two categories:
- The checkbox, one-size-fits-all company…likened to a fully loaded freight train that brings, to each trip, anything and everything you could possibly need. And while you probably won’t have a use for everything it carries, you have no choice.
- The customer-centric, flexibility-focused organization…similar to a well-crafted, thoughtfully-designed sport utility vehicle (SUV). Responsive to the needs of the passengers. Capable of navigating nearly any terrain….safely and efficiently.
If you, as a Sponsor, elected to take the train, and something unexpected happened during your Phase I-IV clinical trial journey, your options are limited:
- You’re locked onto the tracks and you will go only where the tracks take you.
- Forget about discussing options with the driver. The engineer isn’t going to talk with you. And even if you do get to talk with someone, your options are restricted to continue, reduce speed, stop, or reverse.
On the other hand, if you travel by the SUV CRO, you have a greater range of options.
- First, you have a better feel for direction, speed, and control. You know where you are and you know your rate of travel.
- If you become aware of something along the way that could impact your study, you simply ask the driver to detour so you can investigate and make any needed corrections.
The days of the check box CRO are over.
Paragon Biomedical extends best wishes for a happy and joyous holiday season and a bright and prosperous 2011!
Today’s blogger: Jared Byer is Director of Marketing at Paragon Biomedical – a full-service, mid-sized, CRO with offices in the US, the UK, and India
This Is Why Clinical Research Conferences Work So Well
Clinical research conferences serve a diverse audience, including clinical research organizations (CROs), biopharmaceutical and medical device companies (also referred to as Sponsors), academic researchers, regulatory agencies, and vendors. Read more
Select the Right Clinical Research Conferences
Professional conferences, such as the upcoming Partnerships in Clinical Trials meeting in Vienna, Austria, are important because they support the conversations and interactions that strengthen the global clinical research community. Read more