MRA Success Stories

Prospective clients and candidates often ask us why we're so different than other clinical services and staffing providers? With proven results - and lots of them - we like to show the Metropolitan Research Associates difference in action.

Client Background
The client was a small virtual, startup, Biopharmaceutical Company with a promising combination therapy used for the treatment of obesity.

The Trial
A Dose Parallel, Phase 2, Randomized Placebo-Controlled, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Multiple Regimens of the Combination of XXX plus XXX in the Treatment of Subjects with Uncomplicated Obesity

Client Needs
In early 2002, the client needed to execute clinical development for a pivotal trial for their only product. Their continued existence was dependent upon the results of this trial. In addition, like most biotechnology-based companies, funding was limited and had to be used critically and well spent.

Critical needs were:
• Protocol review and modification
• Clinical trial management and monitoring of a 15 site study of 630 subjects
• Regulatory document maintenance
• Site qualification
• Enrollment review
• Patient Recruitment and Newsletter generation
• Review of CRFs and DCF generation
• Vendor Management
• Data Management
• Drug Management
• Central Lab
• IVRS
• Specialty testing specific to Protocol
• Contract Negotiations with Sites and Vendors
• Auditing

Challenges
Like most sponsors, they commissioned bids from several CROs ranging from smaller niche providers to global CROs with all capabilities. They were looking for a partner to grow with and be a focus of their chosen CRO. A key business challenge faced was the absence of any and all infrastructure related to clinical operations and development including project management, CRAs, medical monitoring, data management and any standardized processes associated with the completion of the trial. The core staff were physicians and research scientists and they had little time or money for vendor management or duplicate project management.

Results
After presentations from the top three, MRA was chosen for its flexibility and qualified staff. Our approach proved better suited for our client rather than a global, one-stop shopping approach. Our client wanted careful, extra attention due to the critical nature of the trial. They wanted to feel as important as if they were a huge pharmaceutical company. They had our attention from the beginning.

Our clinical staff was involved from the beginning as was the coordination of our partners. Our bid and strategic plan provided the efficiencies that our client was looking for in a partner. They actually liked the fact that we used niche providers for services outside of our core capabilities and shopped around for the best and most qualified service among our many partners. They also liked that we had a history of success with each of our partners.

After linking our client into an obesity-driven investigator network, MRA quickly got sites up and running and met enrollment deadlines. MRA acted as the one point of contact for all of the niche vendors from contract negotiations to data lock stage.

Long Term Results
MRA is now working on its fifth trial with the client. We have been able to grow with them and accept each trial’s challenges by providing solutions aligned with our client’s overall business strategy.

Important differentiators to note are:
• All of the key staff first involved with this project is still involved to this day.
• Our dedicated team approach has allowed our CRAs to work across all of the client’s protocols with experience and little to no time upfront training.
• We have assisted in helping the client to develop their own SOPs.
• We have also assisted our client in developing their own infrastructure as they grow.
• They now have several products in development at varying stages and we are the CRO for each trial, both large and small.
• Our medical monitor meshed so well with the client, she is now their acting CMO and assisting them with their search for their future Chief Medical Officer.

MRA continues to monitor and manage performance against the implementation plan. We have valued this alliance and built confidence and commitment with not only our client’s teams but the investigator groups as well. The success of this partnership has been dependent upon communication and flexibility. We are committed to continue that practice with future clients.

Pharmacovigilance Case Study

Client Background
The client was a large, well-established pharmaceutical company with marketed products across various therapeutic areas. Prior to partnering with MRA, most safety functions were performed in-house.

The Initial Project
Reconciliation of serious adverse event (SAE) data in the clinical trial database vs. the corporate Safety database (ARISg).

Client Needs
In 2002, the client was interested in outsourcing a relatively small and focused project which involved the review and reconciliation of safety data in the project database(s) vs. the Safety database. However, due to the highly confidential and proprietary nature of safety data, outsourcing this type of project was a new concept for the client.

Critical needs were:
• Review of SAE positive CRFs against the Safety database for select studies
• Resolution of noted discrepancies via updates to the respective database
(involves generating and processing follow-up safety reports or collaboration with clinical teams and CROs for generation of DCFs)
• Review of SAE negative CRFs prior to database lock to ensure all potential SAEs have been detected and appropriately reported to the Safety database
• Unblinding study drug in Safety database at end of study

Challenges
Like most sponsors, the client commissioned bids from several CROs. They were looking for a dedicated team that could function independently but also operate as an extension of their own staff.

A key business challenge involved establishing technical connectivity to the sponsor’s electronic databases. Again, due to the sensitive nature of the data, a sound and secure connection would need to exist before external users would be granted access to the sponsor’s internal systems.

Another challenge was the lack of infrastructure to support the outsource relationship. Since the client was accustomed to having all safety work performed in house, the oversight responsibilities were not yet defined or established.

Results
After meeting with several candidates, the client chose MRA for its qualified and experienced staff and its dedication to service. MRA’s technical capabilities were considered a significant advantage as well.

A small team of Clinical Safety Associates (CSAs) were gathered and trained to perform this function. Training was initially performed in-house by the sponsor and then the group assumed complete responsibility for operation of the project. Over the following months and through many positive interactions between MRA and the client’s internal staff, a collaborative and trusting working relationship
was formed. Points of contacts were established on each side for effective communication and resolution of issues. The project progressed very smoothly and the client was consistently impressed by MRA’s professionalism, and the timeliness and quality of our work.

Through this initial project, the client gained confidence in MRA and became more comfortable with the idea of outsourcing Safety work. When additional projects arose, the client immediately turned to MRA.

Long Term Results
Given the success of the initial project and the proven working relationship, the client awarded MRA several additional safety projects over the next few years. The scope of the work was much larger than the initial project and within a relatively short period of time, MRA’s safety staff expanded ten-fold to accommodate these assignments. In addition to outsourcing the new projects, the client also expanded the scope and requirements of existing projects. The increased responsibility, additional projects and overall level of outsourcing from the client is a testament to their satisfaction and confidence in MRA.

The success of each individual project has led to additional work with the client and corresponding growth of MRA’s safety team. MRA currently has a wellrounded and experienced safety staff including Project Managers, Clinical Safety Associates, Clinical Safety Quality Associates, Clinical Data Coordinators, Triage Associates, and Query Administrators.

A significant factor in the success of this collaboration is the assignment of a qualified, highly trained, and dedicated staff. Many of the key staff who were involved in the initial projects are still involved to this day. This continuity has allowed our safety associates to work across the client’s various projects with experience and little to no time for upfront training. Other factors for success include effective project management, communication and commitment to timely resolution of issues.

MRA continually strives to maintain the high level of performance that has become the standard for this client. With the experience of this successful partnership and a hard-working and trained safety staff, MRA is ready to replicate this model of safety outsourcing to partner with future clients.One of the largest pharmaceutical companies in the world recently needed to develop a team of in-house safety specialists to receive

CANDIDATE SUCCESS STORY

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