The ACMA provides regulatory consulting as a customized stand-alone service or through our full service clinical trials. We can advise sponsors with strategic planning, development, evaluation, and preparation of regulatory submissions at all stages of development and post-marketing.
To optimize the timelines, we have Submission Associates, dedicated to preparing submission files and establishing privileged relationships with Competent Authorities.
If you need clinical project management to oversee all aspects of study conduct, including vendor management, from initiation through closeout, using project management skills to drive a project process to completion, we provide those services.
This includes but is not limited to establishing and setting project timelines, milestones and action items, determining project resources, developing internal and external status reports, identify operational issues and facilitating their resolution, and tracking and managing project schedules and status.
All projects are efficiently handled by qualified project managers who are experienced in various therapeutic areas.
Country feasibility, site and investigator selections are crucial steps for any clinical trials, as it impacts the study for its whole duration.
Effective site management is a cornerstone of every successful research program. Our team selects each study site based on the site infrastructure and access to appropriate patient populations. A recruitment and retention plan unique to each site is prepared, focusing on the site's strengths and experience.
We provide a professional site training, study education and GCP training to speed IRB submission and approval, and to facilitate patient selection, enrollment and randomization
Detailed procedures ensure monitoring of site performance and withdrawal of non-performing or non-compliant Investigators to avoid delays in database lock or analytical deadlines.
Contact us if you need end-to-end management of clinical and ancillary supplies. Our team develops a customized logistics model to meet the unique needs of the sponsor, while ensuring adherence to SOPs of sponsor and regulatory guidelines.
We have highly proficient monitoring staff each member is fully trained on ICH guidelines, and GCP/SOP compliance, experienced in conducting site evaluation visits, site initiation visits, periodic monitoring visits, and study termination visits as well as all in-house monitoring functions, including adverse events reporting, and clinical trial material management.
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Review of study documents, source data verification, Case Report Forms and Informed Consent Forms
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Site contract, budget negotiation, and grant administration
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Site qualification, initiation, and closeout
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Identification and selection of investigators
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Identification and management of IEC/IRB
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Providing protocol waivers, wherever acceptable
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Drug accountability
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Second clinical review
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Data query resolution
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Interim site monitoring
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Handling protocol deviations
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Regulatory document review and collection
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On-site training
A customized logistics model to meet the unique needs of the sponsor, while ensuring adherence to SOPs of sponsor and regulatory guidelines.
Our service begins with providing assistance in obtaining import license and custom clearance of clinical supplies. Depending on the requirements of the sponsor, we also take the responsibility of drug destruction.
