Center InformationApril McCall Vice President, Business Development CROMSOURCE 8000 Regency Pkwy., Ste. 575 Cary, NC 27518 1-800-670-6381 www.cromsource.com/services
Currently Enrolling Trials
CROMSOURCE is an ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries specializing in clinical development and staffing solutions.
CROMSOURCE was founded in 1997, and since that time our successful growth has been built on quality, stability, integrity and high levels of customer satisfaction. These factors all contribute to a high rate of repeat and referral business, providing strong and direct evidence of the quality of our services. We have grown steadily, but responsibly, to become an organization of over 350 organized and well-trained experts.
At CROMSOURCE, we live by our motto – Advise, Agree, Deliver. This means that we leverage our experience and expertise at the early stages of discussions with our clients to advise them on the optimal plan to advance their novel therapeutic agent or medical device. We then reach agreement with each client on the approach, scope of services, timelines and budget.
A well-established full service CRO, CROMSOURCE is unique in offering an end-to-end guarantee covering trial timelines, enrollment and contract price. This guarantees our clients that their trials are delivered on time and within the contract price without CRO-initiated change orders.
Acting through our expert teams and with a comprehensive portfolio of services, we offer a flexible approach to ensure that CROMSOURCE supports the unique needs of each client. This could mean providing regulatory consultancy to a small company at the early stages of a medical device development program or provision of full services to a pharmaceutical company performing an international trial to support global registration of their product. Whatever the size and scope of the project, each receives the same level of attention to detail and commitment to delivery of a high-quality service within budget and within the agreed timelines.
The CROMSOURCE advantage consists of:
- Consistent quality systems across the entire global business;
- Executive oversight that removes the bureaucracy from escalation and rapid decisionmaking;
- Consistently on-time, within-budget project delivery;
- Low employee turnover resulting in consistency and continuity across the program from start to finish;
- Global presence;
- Local expertise; and
- Big enough to perform large, global trials yet small enough to offer flexibility and attention to customer service.
CROMSOURCE is committed to providing flexible services to support every aspect of our clients’ needs. We offer a comprehensive portfolio of services that can be tailored to meet the individual needs of each client, including:
- Strategic consulting
- Feasibility and site selection
- Study start-up
- Project management and clinical monitoring
- Data management and biostatistics
- Medical monitoring
- Medical writing
- Quality assurance
- Vendor management
- Legal representation
- Technology solutions
- Flexible resourcing solutions
CROMSOURCE has embraced, developed, and invested heavily in technology relating to clinical research. This has resulted in the formation of our associated company and wholly owned subsidiary, Techorizon (www.techorizon.com)
Flexible Resourcing Solutions
TalentSource Life Sciences is the dedicated, flexible resourcing department within CROMSOURCE, led by experts in the flexible resourcing industry who understand the industry trends.
With more than 25 years of experience providing high-quality clinical research professionals, we are able to add real value to our client’s work by allowing them to efficiently adjust the size of their team to manage peaks and troughs in their workload.
We can initiate services in either a functional service provider setting or by providing short- and long-term resources for our clients’ organizations. We specialize in supporting clients of all sizes from large global companies to virtual biotechs. TalentSource works with our clients closely, drawing on the experience of CROMSOURCE to provide experts who are ready and able to add value to our clients in their specific assignments.
We do not believe that "one size fits all,” rather, we listen to our clients and propose a customized solution that fits their specific needs. In essence, we do not provide a standard FSP model or a standard retained FTE model; we provide a custom-designed solution that perfectly addresses all of the client needs. TalentSource is currently providing flexible resourcing solutions in more than 40 countries, with experts in virtually every therapy area.
CROMSOURCE has the global reach to conduct biopharmaceutical and medical device studies around the world. With world headquarters in Verona, Italy, CROMSOURCE is a leading CRO in Europe and the U.S. with offices, a solid infrastructure and operational subsidiaries in Belgium, Germany, Poland, Russia, Spain, Switzerland, the UK, the Netherlands and the U.S. U.S. offices are located in Newton, Mass., and Cary, N.C.
From these office locations in Europe and North America, CROMSOURCE employs experienced field-based teams in locations across the globe to provide expert capabilities in regions including the Middle East, Africa, APAC, and South America.
Put simply, One Trial One Price is our unique pledge that the price agreed at contract signature is the only price that the client will pay. CROMSOURCE provides our clients with a concrete budget, which contrasts markedly with the change-order culture prevalent in today’s CRO industry. It is the embodiment of the CROMSOURCE commitment to deliver high-quality data to our clients, on time and on budget.
CROMSOURCE believes that a rigorous assessment of country and site level feasibility is critical to trial success and must be implemented early in trial planning. Without detailed and accurate feasibility data on which to base country and site selection, a reliable prediction of enrollment rates and, therefore, successful planning of trial milestones is impossible. If your last trial was delayed by recruitment issues, you may wish to consider the level of detail you were provided within the feasibility assessment.
Working closely with our sponsors, CROMSOURCE identifies those geographic areas well known for their prevalence of the targeted indication. All regulatory requirements are then reviewed and timelines developed for each country to ensure fast regulatory approvals.
CROMSOURCE then works directly with the most professional and productive sites in every area of the world. Sites are only considered if they have proven they can deliver a combination of high enrollment, high retention and quality data. Each site is asked to identify potential patients far in advance of study start-up, thus assuring there are no surprises during the enrollment phase.
Quality data. On time. On Budget. Guaranteed.
At CROMSOURCE we believe experts should keep their word. With nearly 25 years of success in supporting our clients to meet their clinical research goals we have a solid history and experience with highly productive geographies, sites, investigators and regulators. We are so confident in our abilities to deliver your study on time and on budget that we are able to offer the industry’s only end-to-end guarantee.
Starting at the RFP stage with our uniquely detailed Feasibility Plus process (delivered free and without obligation), we ensure that we provide realistic predictions of enrollment and timelines and recommend the right mix of countries and sites. Our end-to-end guarantee then covers the following areas:
- Your study will start on time;
- We will enroll 100 percent of the contracted patients;
- We will finish on time with a set date for database lock; and
- The price you contracted is the price you pay. There will be no CRO-initiated changes in scope.
Furthermore, we know that budgets must be competitive, so you can rest assured that our end-to-end guarantee does not come with a premium price.
Does your trial need help to get back on track? CROMSOURCE has rescued many trials from missing their goals, while providing expert guidance on the best ways to make a failing trial succeed.
We know where the patients are and how to enroll them. We know which countries have the highest prevalence of various diseases and the sites that consistently deliver the highest volume of qualified patients.
And, because we monitor competing studies in all major markets, we help our sponsors understand the competitive landscape and direct them to markets with the patients needed to finish their study on time.
Finally, a sponsor’s rescue study may qualify for our end-to-end guarantee. If your study meets certain requirements, we will guarantee not only the specified number of patients but also the date of database lock.