Clinical Trials
Leading Our Clinical Research Service
Kym Denny, Vice President, Clinical Research
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We work in many therapeutic areas, covering every aspect of clinical research, from individual Phase I studies to complete Phase IV programs. Our clinical team has coordinated international multi-center trials and has managed a variety of specialized niche studies, including volunteer studies in academic units, trials based at GCP-naïve sites in African countries, studies of pediatric populations, and Phase I studies of genetically modified products.
Our Success Conducting a Phase III HIV Clinical Trial
Constella is conducting a Phase III multiple-center study on a delivery system for administering an HIV drug. Constella is providing comprehensive project management, clinical monitoring, and data management for the study, which involves 300 HIV-positive subjects at 60 sites located in the United States and Puerto Rico. When we initially began the project in 2005, the client, a U.S.-based pharmaceutical company, expected enrollment to occur over a seven-month period. Constella was able to successfully enroll all subjects within three months.
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Recognizing that no two projects are the same, Constella provides a flexible service that is tailor-made to the requirements of the individual client and project. We can take full responsibility for a project, from protocol design, study coordination, data management, and statistical analysis, right through to the submission of a study report. Our staff is experienced in working alongside the client’s employees and managing the relationship with third-party contractors with the aim of creating a fully integrated project team.
Alternatively, we can offer stand-alone services, such as project management or monitoring, giving you just the level of assistance you require. Our clinical research services include project management, clinical study monitoring, medical/safety monitoring, feasibility studies, phase I-IV program management, full service (protocol design to clinical study report), investigator recruitment and qualification, investigator meetings, case report form development, clinical study tracking, and investigator contracts and payments.
Project Management |
Constella provides experienced project managers to oversee each clinical study. Our project managers have a scientific background and serve as the single point of contact for our clients. We can also provide stand-alone project management services. |
Clinical Study Monitoring |
We offer clinical trial monitoring services across all phases of clinical development. Our monitors are typically allocated to only one clinical trial, ensuring their focus on your study. Our monitoring teams garner high praise from our clients, investigators, and coordinators, a key factor in Constella’s high rate of repeat business. |
Medical/Safety Monitoring |
Our medical directors have close communication with the monitoring teams and with our clients. We offer 24-hour safety monitoring services for clinical trials we conduct as well as stand-alone medical monitoring for trials in which we are not otherwise involved. Our medical directors are involved with the preparation of IND safety
report and SUSARs
as well as patient safety narratives. |
Investigator Recruitment and Qualification |
Constella has an extensive database of qualified investigators across
an array of therapeutic areas. Using this database, our knowledge and experience,
the medical literature, and our client’s input, we can take responsibility
for the initial identification and recruitment of investigators. Our process
includes a detailed evaluation of each investigator, study coordinator, and
other site resources as well as an evaluation of the available patient population
and facilities at the site. We understand the ultimate success of a clinical
trial often begins with the selection of the appropriate investigators. |
Investigator Meetings |
We can assist with the logistics and the management of Investigator Meetings. Our role is flexible and depends upon the needs and expectations of our clients. Often our project teams prepare and deliver presentations of key materials at the meetings. |
Case Report Form (CRF) Development |
We believe that a well-designed CRF plays a critical role in the efficient implementation of a clinical trial. We strongly advocate having our clinical and data management teams involved in the design or review of the CRF. This allows our teams to identify efficiencies that can reduce the need for later clarification and facilitate a quick database lock. |
Clinical Study Tracking |
Constella has developed proprietary study tracking tools that allow us to give our clients updates on study progress at any stage in the clinical trial. All of our documentation can be customized to meet the specific needs and expectations of our clients. This includes tracking tools that detail the collection of the requisite regulatory documents to details on patient enrollment and safety issues. |
Investigator Contracts and Payments |
Our role in investigator contracts and payments can be tailored to the needs of our clients. We can hold the contract with the investigative site and administer the payment. Alternatively, our clients can choose to negotiate and hold the investigator contracts. We can still administer the requisite payments, as requested.
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