The Harte Group enlists a team of industry-seasoned professionals who are capable of assisting your company with strategic growth while leveraging Contract Research Organization (CRO) support, either through full service or functional/specialty service providers.  The Harte Group can assist the sponsor companies with the following:

·       CRO selection, qualification and clinical trial management

·       Service Level and Quality Agreements for CRO services

·       Integrating sponsor and CRO work processes

·       Develop and implement ongoing quality checkpoints

·       Identify quality measures and deliverable standards for CRO work product

·       Processes and standards to analyze the CRO’s infrastructure and staff assigned to the study

·       Develop a program to manage risk, escalate issues (CAPA) and effectively collaborate with the CRO

The Harte Group specializes in Vendor Oversight and Quality Management programs of Contract Research Organizations (CROs) for sponsors who leverage clinical trial outsourcing as a means to extend their core competencies.  The Harte Group is able to utilize either traditional CRO models or supplement sponsor teams with functional and specialty service providers which aid the creativity, flexibility and experience that our more virtually-operating clients demand.

With a focus on Clinical Trial Project Management, The Harte Group will assign a seasoned industry executive to act as the sponsor’s point of contact.  The Project Manager will coordinate with the sponsor to select and qualify the appropriate CROs, discussing strategy and coordination between parties to ensure complete Service Level and Quality Agreements.  Once selected, the Project Manager will establish timelines for deliverables across all vendors, collect and review all plans, and infuse a quality assurance program to ensure that the CROs will adhere to their own work practices and those identified by the sponsor.

The Harte Group can support the selection or oversight of the following areas:

• Quality Assurance and Quality Control
• Site Selection and Support
• Patient Recruitment and Retention
• Clinical Trial Management Services
• Clinical Trial Project Management
• Clinical Monitoring
• Medical Safety
• Data Management
• Biostatistics
• Medical Writing
• Clinical Supplies
• Service Level and Quality Agreements (CROs)
• Contract and Budget Negotiations (Sites)
• Grant and Vendor Payments
• Regulatory Affairs
• Clinical Technologies Support

Integrated Project Delivery and Accountability

 The Harte Group can provide more freedom and flexibility than a CRO operating with a traditional model, with three or more partners available to work in every functional area.  We can be creative in structuring a CRO services team for each trial, giving you access to the best and most experienced companies for your particular needs, or work with your current selected partners to enhance the working relationship between the sponsor and CRO partner.

Following review of your program or protocol, we will evaluate, select and present the best team approach for the opportunity, choosing and managing a core group of vendors who best fit your study or program needs.  Additionally, The Harte Group provides the clinical trial management services to oversee the vendors' activities; everything from protocol development to the clinical study report to minimize rework and complete projects on time, on budget and of high quality.

The Virtual CRO

A Changing Industry Demands a More Flexible CRO

Traditional Contract Research Organization (CRO) models have long been the choice of pharmaceutical, biotechnology, and medical-device companies for R&D support services and clinical trial outsourcing.

The traditional CRO is built to handle large blockbuster drugs and large clinical trial programs, which require tremendous overhead, resources, and support.  But the era of the big blockbuster is over.  The pharmaceutical industry now faces tremendous challenges:  depleting pipelines, patent expirations, and shorter drug-development times.

The focus of today’s pharmaceutical, biotechnology, and medical device companies has shifted to smaller clinical trials and investigator initiated studies that target specific populations and are overseen by smaller, virtual teams.  The support of these teams will demand clinical trial management companies that demonstrate a high degree of flexibility and provide access to experienced staff who proactively contribute to the overall strategy and execution before and during the study.

Redefining the CRO

The Virtual CRO model is built for today’s leaner biotech and pharma companies, providing the flexibility, experience, and accountability demanded by today’s faster and more focused clinical trials.

Instead of the “everything under one roof” model followed by the traditional clinical research organization, a Virtual CRO (like The Harte Group) will have a network of over 100 companies, each with years of in-depth experience and specific expertise that can ensure the success of today’s smaller, earlier trials.

The Virtual CRO acts as a central “general contractor” for all projects, using integrated communications and clinical trial project management tools to coordinate the team and providing the sponsor with a single point of contact, one contract, and one invoice.

The Benefits of Using a Virtual CRO

Virtual CROs offer these benefits to sponsor companies:

·       Reduce the time needed to initiate projects

·       Focus on best-of-class provision of specific CRO services

·       Provide targeted, cost-effective use of experienced professionals

·       Simplify complex processes with quality measurements

·       Increase and decrease resources and activity without affecting internal head count

·       Allow sponsors to focus on their core competencies

·       Manage multiple clinical trial management vendors through a central point of contact

Working with a Virtual CRO enables pharmaceutical, biotech, and medical device companies to move products through development more quickly, using creative and innovative approaches.

All the Support of a Full-Function CRO

Virtual CROs offer all the features, functions, and services of a full-function clinical trial CRO.  With a network of over 100 functional service providers (FSP), a Virtual CRO has two or three options to call on for any clinical study requirement.  There is not a service area or therapeutic area that a Virtual CRO cannot deliver.

The only difference is that a Virtual CRO doesn’t have these teams waiting around when they are not needed, sitting idle, as they would be in a traditional CRO.  Instead, they are called on only when needed, dramatically reducing overhead.

With Greater Flexibility, Experience, and Accountability

Because its network of functional service providers (FSPs) gives it two or three options to call on for any clinical study requirement, a Virtual CRO has the flexibility to select exactly the right expertise needed for each study.

Many of these FSPs have decades of experience in a particular area and offer expertise that cannot be found anywhere else.  All-in-one, traditional clinical trial outsourcing companies cannot afford to retain this sort of specific expertise on-staff.  Working with a Virtual CRO gives you direct access to this expertise before and during your clinical trial, often helping you avoid costly mistakes that can delay or sabotage your trial.

Virtual CROs offer greater accountability than traditional CROs.  In a full-function clinical research organization, when a failure in one department causes additional work in another department, often the client is simply billed for the out-of-scope work.  The underlying problem may never be corrected.  In a Virtual CRO, the FSPs are often working on a fixed contract basis, so any out-of-scope work caused by a failure by another team member will be surfaced quickly and dealt with directly.  The Virtual CRO’s integrated communications and clinical trial project management tools ensure that all team members are working together smoothly and effectively to meet the goals and deadlines of the trial.

To learn more, contact The Harte Group by phone at 215-766-2397, or e-mail at info@hartegroup.com)