Aptuit, Inc. Offers Design, Implementation and Analysis of Phase I Standard and Fusion Studies
Published: Oct 25, 2012
“Our capabilities frame Phase I clinical trials, standard Phase I studies, fusion studies, PK/PD imaging, PSG, EEG, QTc, multicenter studies, adaptive design studies, human model and challenge studies with the initial design of the study, the setup and ongoing management of the study and the subsequent analysis and interpretation of safety, PK and PD data in the context of the further clinical development of the compound,” said Mr. Needleman. He explained that since Aptuit does not have Phase I capabilities in house, there is no internal pressure to fill a Phase I unit, so there is never a compromise related to workflow or business margins.
“Our abilities in advancing this crucial developmental phase are essential and particularly advantageous from the client’s viewpoint. Initially, we address the client’s needs by custom designing the study, something that we have been doing for a long time. The many discovery-through-development projects that we have successfully completed over the years place us in excellent position to identify the best resources for Phase I studies. We are aware of factors such as available capacities, expertise, timeline and cost issues. We can be totally objective in selecting the resource that will best meet the client’s needs. This awareness is an extremely important factor in our identification and choice of the best resource for a particular Phase I study.”
Once the Phase I site has been selected, Aptuit offers end-to-end clinical study operational leadership, covering all phases of a clinical trial life time, from study concept, submission to regulatory/ethics authorities, study implementation and conduct, up to the delivery of the final study report within agreed timelines and at the highest quality.
Mr. Needleman stated, “We are prepared to assist in the implementation process, making ourselves available throughout the study’s duration, and supporting activities with our knowledge and expertise.”
Stefano Zancan, Clinical Sciences Head at The Aptuit Center for Drug Discovery & Development in Verona, Italy, cited the Clinical Sciences team’s experience with various Phase I studies and stated, “The extent of our expertise is all encompassing and much of what we have done has been related to designing the best clinical study, starting from the integrated assessment of the preclinical data package to model human exposure, adverse events and clinical response, factoring in various doses and regimens that help design a safe and informative first-in-human study. The study itself may be enriched by PD assessments that provide available information on study stoppers and potential efficacy of the compound at an early stage. Clinical Sciences combines multiple objectives within a single study, and since these objectives were traditionally being pursued using separate protocols, the client gains the opportunity for timeline and cost savings.”
Mr. Zancan added, “We can act as a single point of contact for clients, managing all vendors and third parties, implementing what the clinical study or project requires according to the client’s needs.”
Mr. Needleman concluded, “For pharmas and biotechs with need of quality Phase I studies, Aptuit is the resource that can provide assurances and oversight needed every step of the way.”
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Aptuit LLC provides the most complete set of integrated early to mid-phase development services in the industry. Drug Design & Discovery, Preclinical Biosciences, Sterile Fill/Finish, Formulation Development, API Development and Manufacture, Solid State Chemistry, Clinical Sciences, Consulting and Aptuit INDiGO® (a program that accelerates drug development) are offered as stand alone or integrated services. Fully integrated drug discovery & development services are available from a single site at The Aptuit Center of Drug Discovery & Development in Verona, Italy.
Aptuit LLC maintains seven global facilities with more than 800 employees in Europe and the United States and has a partnership agreement with Laurus Labs in India. Aptuit LLC is partnered with Welsh, Carson, Anderson & Stowe, one of the world’s leading private equity investors.
For more information about Aptuit, visit www.aptuit.com.