CROMSOURCE

Contact Information

April McCall
Vice President, Commercial Operations
CROMSOURCE
309 Waverley Oaks Road, Suite 101
Waltham, MA 02452
1 617.871.1128
1 617.871.1129
April.McCall@cromsource.com

Corporate Overview

Since 1997 CROMSOURCE has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting quality and client focus at the heart of everything we do.

At CROMSOURCE we live by our motto – Advise Agree Deliver. This means we leverage our experience and expertise at the early stages of discussions with our clients to freely advise them on the optimal project plan. We then reach agreement with each client on the scope of service, timelines and budget. CROMSOURCE then commits to delivering those services on-time and within budget – according to our End-to-End Guarantee. Our commitment to guaranteed delivery is unique in the clinical research environment which is otherwise notable for the routine occurrence of delays and cost overruns.

Acting through our expert teams, and with a comprehensive portfolio of services, we offer a flexible approach to ensure CROMSOURCE optimally support 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, through to provision of full services to a pharmaceutical company performing an international trial to support 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.

History

CROMSOURCE has a rich history dating back to 1997 with the founder, Oriana Zerbini, MD, continuing at the helm. Our successful growth over the last 20+ years has been built on stability, integrity, high levels of customer satisfaction and repeat business. We have grown steadily to become an organization of over 500 employees with offices across Europe and North America. Our commitment to providing the right services has allowed us to be at the forefront of developments in the industry; from pioneering the provision of contract staffing solutions in Northern Europe in the mid-90's to being early adopters of the ISO Quality Management certification in 2000.

CROMSOURCE was also among the first CROs to become active in Central and Eastern Europe and Russia fifteen years ago, and continues to have unparalleled local experience in these important regions. More recently, CROMSOURCE led the way again, being the first CRO to provide a ‘One Trial One Price’ fixed budget guarantee in 2011. As a result of our experience and capabilities, we have been able to build on this pledge and in 2012 we incorporated a fixed timelines pledge – creating our End-to-End Guarantee. In a world where the majority of clinical trials are delayed and over budget, our clients can concentrate on the bigger picture knowing that their project will be delivered on-time and within budget by a high-quality partner.

Services

CROMSOURCE is committed to providing flexible services to support every aspect of our clients’ needs. Please select a service area to learn more about our comprehensive services and problem solving approach https://www.cromsource.com/services/

TECHNOLOGY

Since our inception over 20 years ago, CROMSOURCE has embraced, developed, and invested heavily in technology relating to clinical research. This resulted in the formation of our associated company and wholly-owned subsidiary, Techorizon Srl (www.th-clinical.com).

We believe that technological innovation is essential to streamline workflow, enhance decision making, and improve the quality and efficiency of clinical trials. By remaining at the forefront of creating and developing ground-breaking technological solutions, our experts help us deliver faster, efficient services and allow our teams to work smarter and faster on your projects.

The new TheClinical 3.0. delivers enhanced functionality in a fully-integrated environment. From the feasibility study to the final study report, this platform offers many solutions for each stage of a clinical trial.

By means of PC, tablet or smartphone, all services are securely accessed with the use of the most advanced encryption standards available today.

Pharmaceutical

  • Feasibility

  • Project Management

  • Clinical Operations

  • Biometrics

  • Medical Affairs

  • Regulatory Affairs

  • Safety Services

  • Medical writing

  • Flexible Resourcing Solutions

 

  • Feasibility

  • Project Management

  • Clinical Operations

  • Biometrics

  • Medical Affairs

  • Regulatory Affairs

  • Safety Services

  • Medical writing

  • Flexible Resourcing Solutions

 

Through our TalentSource Life Sciences division, CROMSOURCE continues to lead the way in providing flexible staffing solutions. With over 20 years’ experience of providing high quality clinical research professionals, we are able to add real value to your work by allowing you to efficiently adjust the size of your team to peaks in workload. We are equally comfortable acting in a functional service provider setting or in simply providing short and long term or permanent staff for your organisation.

 

      • Biostatistics
      • Clinical Data Management

 

      • Early Phase Services

Locations

CROMSOURCE has been active in the Central Eastern European area since its inception in 1994, and as such has enormous experience in these regions. CROMSOURCE has an extensive European infrastructure and operates subsidiaries in Germany, Spain, Belgium, Poland, Ukraine, Russia, the UK, the Netherlands and the USA. These subsidiaries, and our field-based staff located in many other European countries provide an established infrastructure through which CROMSOURCE is active across the whole of Europe and the USA.

EUROPE

Belgium, Germany, Italy, Poland, The Netherlands, Spain, UK, Russia, Ukraine

UNITED STATES

East Coast,West Coast

Description of a unique characteristics of our facilities

Put simply, One Trial One Price is our unique pledge that the price agreed at contract signature is the only price that the Sponsor will pay. In this way, 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 enrolments rate 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 with in the feasibility assessment.

Moreover, CROMSOURCE strongly believes in “Quality by Design”: a determination to review from the very beginning all aspects of operations, with a view to proactively identify and prevent quality issues and operational threats rather than relying solely on the ability to react to issues when they arise. A detailed and reliable feasibility analysis is one of the crucial first steps in the process.

For these reasons, CROMSOURCE have developed our unique Feasibility PlusTM approach which is provided without obligation at the RFP stage to potential sponsors. This stringent methodology is the foundation of our ability to deliver our End-to-End Guarantee.

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 timeliness developed for each country to ensure fast regulatory approvals.

CROMSOURCE then works directly with the most professional and productive sites in each geography. Sites are only considered if they have proven they can deliver a combination of high enrolment, high retention, and quality data.

Further, each site is requested to identify potential patients far in advance of study start-up, thus assuring there are no surprises during the enrolment phase.

With the accurate and detailed trial planning data provided by Feasibility PlusTM CROMSOURCE can offer Sponsors a comprehensive End-to-End guarantee, assuring them that their study will be completed on time and on budget with no CRO initiated changes in scope.

Our Feasibility Plus process is such a valuable tool that CROMSOURCE are often requested to assist clients with rescuing trials which are delayed due to poor recruitment. We implement Feasibility Plus as part of our Expert Trial Rescue service.

 

It’s a simple concept, really. Quality data.On time.On Budget. Guaranteed.

At CROMSOURCE we believe experts should keep their word. After 18 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 PlusTM 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:

      1. Your study will start on time
      2. We will enroll 100% of the contracted patients
      3. We will finish on time with a set date for database lock
      4. 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, and you can rest assured that our End-to-End guarantee does not come with a premium price. Don’t you owe it to your project to learn more? Contact us here to request more information.

 

Is your current trial is running behind schedule, or you would like support from a CRO who are experts in rescuing such studies?
If so, that’s where CROMSOURCE can help.
We’ve been involved in more rescue studies than other CROs have total studies.

That’s because 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. We then advise them to avoid those countries and re-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.

Now that’s what we feel a study rescue is all about. To ask how we can help bring your study in on-time, click here.

Contact Information

April McCall
Vice President, Commercial Operations
CROMSOURCE
309 Waverley Oaks Road, Suite 101
Waltham, MA 02452
1 617.871.1128
1 617.871.1129
April.McCall@cromsource.com

Contact Company

If you are interested in contacting this company, please complete and submit the form below. A representative from the company will follow up with you.