Advent CRO Services

With a decade of experience conducting clinical studies, Advent Research has assembled and refined a paramount team dedicated to supporting the endeavors of our sponsors through strict adherence to protocol and quality assurance demands. As an organization, our highest priority is the expediting and assisting of bringing our clients' drugs to market as an organized, focused clinical partner.

Our research services include but are not limited to:

• Protocol development
• Volunteer recruitment
• Coordinator training
• Clinical conduct
• Monitoring
• Data management
• Clinical and statistical reports
• Medical writing
• Quality assurance

Phase I

With expertise in managing complex, procedurally intensive Phase I studies, Advent Research provides customized services to advance your product to the next development phase. Our capacity to accommodate large trials combined with our dedicated, experienced staff delivers integrated planning and implementation of Phase I trials. Advent offers comprehensive Phase I and IIa clinical trial management dedicated to drug studies. Our clinical professionals have the experience and resources to provide integrated management of global early phase development programs.

Phase II - IV Clinical Services

Our principal objective is to provide the pharmaceutical and biotechnology industries with the range of services required to meet our clients' clinical trial management needs.

Project Management

Our project managers provide quality deliverables on-time and on-cost, resulting in effective Phase II-IIIb programs. Your project manager will be fully trained in the therapeutic area being studied, have exceptional organizational skills and possess a remarkable ability to anticipate risks and drive the study smoothly through to completion.

Whether managing a single service scope of work or a full-service global program, Advent project managers are experienced team leaders focused on providing on-time, on-cost quality deliverables. From the outset of each project, your project manager develops a strong relationship with you based on clearly-defined expectations and objectives.

Clinical Monitoring

Experienced clinical monitoring teams deliver quality, timely results. Assigned by therapeutic experience, Advent provides consistent, effective interaction with study sites.

Advent Research's in-house physicians provide round-the-clock medical-monitoring services as well as scientific and medical support for project management teams and investigative sites. To meet stringent timelines for regulatory compliance and Serious Adverse Event (SAE) follow-up, SAE/AE collection, evaluation, classification, reporting, and reconciliation; and total drug safety management. A dedicated clinical team of highly skilled and well-trained Advent professionals provides consistent and effective monitoring and interaction with study sites. To ensure seamless communications with your organization, a single project manager serves as your contact for all aspects of your study.

Between monitoring visits, CRAs call investigators weekly to verify patient enrollment status, review study progress, answer protocol questions, discuss CRF completion and ensure the study proceeds in a timely manner. CRAs make final visits to sites to close out studies after all subjects have completed or have been discontinued from the study and after all queries have been resolved.

Data Management

Advent works closely with the sponsor's data mangement and clinical personnel, statisticians and programmers to develop detailed specifications for collection, processing and cleaning of data and a formal quality control plan. Advent provides data management expertise and comprehensive data management services for Phase I-IV clinical trials. We have expertise in a broad range of therapeutic areas including orthopaedics, pain management, oncology, dermatology, endocrinology, gynecology, heart and vascular, and gastroenterology.

The data management planning process emphasizes close communication with the sponsor through all phases of development and review of database specifications. Quality control mechanisms monitor every major element of the data management process, and Advent helps maximize the client's technology investment through guidance in the most effective use of appropriate technology according to the sponsor's particular needs and preferences.

Quality Assurance

As well as being a standard part of our operating procedures, Advent Research Quality Assurance services can help you design and implement appropriate internal quality systems and processes, regardless of your time zone or language.

In drug development projects, we help you align your procedures and databases with the multiple regulatory requirements involved. We also provide individualized service for locally managed projects.

Our comprehensive array of services includes:

• Computer System Validation Reviews
• Investigator Site Audits
• Database Audits
• SOP Management
• Quality Systems Training, Development and Implementation
• Corrective Action Systems Implementation

Complete Regulatory Services

Advent's regulatory affairs staff provides the most effective regulatory assessment and strategy for product development. Flexible and responsive to your needs, Advent's regulatory affairs team represents or supports you in meetings with regulatory authorities, provides scientific advice and defines your regulatory strategy. We offer a broad range of services to assist with regulatory needs:

• Full service regulatory consulting
• Strategy and planning Conducting competitive intelligence surveys
• Prioritizing projects with the greatest chance for approval
• Facilitating product authorization by regulatory authorities

Experience

Advent understands the needs and challenges faced by a successful program as well as the dynamics of effective patient recruitment. Advent starts by profiling your target patient population which enables us to design a program that effectively blends available media into a custom campaign that can include television, radio, print, Internet and direct mail. Our experience with these media offerings, pricing and reach, ensures the most cost-effective plan possible for your study.

Our patient recruitment experience encompasses a wide range of therapeutic categories, including cardiovascular, respiratory, oncology, gastrointestinal, metabolic, dermatology and women's health. We have also managed programs of all sizes - from a few hundred calls during several months to thousands of calls over a few weeks.

Targeted Marketing Strategies

Effectively designed media programs help ensure that Advent will generate the calls needed to meet client enrollment targets. The highly trained call center staff, using a study-specific screening questionnaire and sophisticated patient scheduling database system, can help shorten enrollment timelines.

Site Support

The patient recruitment process can be time-consuming for site staff. That is why Advent developed a suite of site-support services that help sites stay focused on the clinical needs of a study rather than recruitment management. When a study requires it, the call center is staffed with medically trained support specialists to handle sensitive health-related issues or more in-depth screening.

Patient Recruitment and Retention

Advent offers broad recruiting experience that delivers custom programs designed to attract qualified patients. Providing tailored support services for recruitment and retention allows study site personnel to stay focused on clinical needs. Experienced project managers work with studies of all sizes and complexities, including rescuing current projects experiencing difficulty meeting enrollment goals. Patient recruitment services can shorten your clinical study enrollment timeline and speed the recruitment process with:

• Targeted marketing strategies that attract qualified patients from diverse populations
• Site support services to assist study site personnel
• Sophisticated telecommunications center technologies that centralize data collection for real-time reporting and tracking
• Patient retention services to improve compliance among study volunteers

Keeping patients active in a study is a challenge. Advent offers a variety of patient retention services designed to motivate patients and maintain high study compliance. These programs include:

• Visit reminder calls and cards
• Patient education materials
• Suitable compliance incentives

Why Advent Research?

We have assembled a unique collection of skilled specialists working together, every one of whom is personally committed to giving you the best possible service. With us you will always have access to your project manager as well as our senior staff. To us you are not just another client, you are our number one priority and we prove it to you. We are committed to the highest standards, yet flexible enough in our approach to become an integral part of your internal team.