Clinical trial management |
We design, manage, and conduct Phase 1 through Phase 4 clinical studies, ever mindful that quality, time, and cost are critical to sponsors. Our approach focuses on effective, mutual communication, partnership, and flexibility in developing strategies with your specific needs in mind. We recognize that one clinical study approach does not fit all. Our experienced project teams not only create individualized strategies, but also support this work with advanced protocol and case report form development to keep the project on track. We can completely manage your clinical development program or integrate with your staff as a true extension of your company. By partnering with us, you can ensure that your clinical trial gets the attention it deserves. |
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| Patient Recruitment and Retention |
Finding the required numbers of patients is one of the largest obstacles facing clinical trials today. We acknowledge that it's of critical importance to sponsors to recruit and retain trial subjects who meet the inclusion criteria. We have the necessary skills and experience to develop and execute effective marketing strategies to meet your patient recruitment goals. |
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| Onsite monitoring |
| We provide ongoing monitoring of your clinical trials. Our CRA's are highly trained and experienced. At each monitoring visit, CRA's review: |
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Protocol compliance, |
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CRF accuracy and completeness; 100% check against source documents, |
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AE reporting, |
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Trial progress, |
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Enrolment, |
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Suitability of participants, |
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Continued acceptability of investigator and facilities, |
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Filing and maintenance of source documents, |
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Drug inventory and accountability records, |
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Compliance of investigator's document file, |
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Collection of data for interim analysis. |
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| Final data review and preparation of clinical study reports |
At the conclusion of the investigator's participation in your clinical trial, a final monitoring visit takes place. At this time, CRA's: |
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Ensure that all CRF's and any queries or addenda are collected, |
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Complete an inventory of drug supplies, |
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Reconcile accountability and distribution forms, |
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Return drug supplies to you, |
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Review all relevant documentation, |
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Give final instructions to investigator and personnel. |
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| Pharmacovigilance |
| Our Pharmacovigilance team has the education, training, and experience to provide a comprehensive range of safety reporting services that meet the global demands of SAE reporting requirements for drugs, biologics, and devices from clinical studies (Phase I through IV) through post-marketed safety surveillance. At our center, the complete safety profile of a product can be maintained from clinical development through the lifecycle of the product. To enhance regulatory compliance, a Medical Monitor is assigned to every project and is accessible 24 hours a day, every day to handle critical situations. |
| The responsibilities of the monitoring physician include: |
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Reporting serious adverse effects to the sponsor and to the FDA, according to the SOPs and FDA requirements |
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Writing narrative descriptions of both significant and serious adverse effects for inclusion in the Final Study Reports |
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Clarifying inclusion/exclusion criteria with the investigator |
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Providing consultation for potential safety issues or medical concerns regarding the clinical study. |
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