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Clinical Phase Services
50 services found
Manufactured by:Applied Pharma Research s.a. based inBalerna, SWITZERLAND
APR has a dedicated clinical department that is involved in all stages of the clinical trial program from designing protocols to supervision, monitoring and conduction of clinical studies. We work with a network of existing partners or those selected by our ...
by:Vetter based inRavensburg, GERMANY
Learn how we work with you to design a flexible, scalable, reproducible, and efficient manufacturing processes for your clinical ...
Manufactured by:Nexelis based inSeattle, WASHINGTON (USA)
From Fit-for-Purpose Development to Qualified and Validated Clinical Assays. Nexelis, a Q² Solutions Company, is a leading partner in assay development and technology transfer, with scientific discipline, critical thinking, and agility. Fit-for-purpose assay development on a wide variety of platforms support your small molecule, large molecule, or vaccine program through all ...
by:Patheon Inc. based inDurham, NORTH CAROLINA (USA)
In late clinical phases, and as part of the establishment of your commercial supply, Patheon provides a complete validation package according to regulatory and cGMP ...
Manufactured by:BIOVECTRA based inCharlottetown, PRINCE EDWARD ISLAND (CANADA)
They review methods and processes in-depth with our clients’ subject matter experts to map tailored development and commercialization paths, allowing us to improve the likelihood of success. Our nimble, phase-appropriate approach to pre-clinical and clinical material supply enables our clients to move quickly and cost-efficiently through ...
by:Cytovance Biologics based inOklahoma City, OKLAHOMA (USA)
Services include cell line development using Freedom® CHO-S® (Life Technologies), microbial strain development using GeneGPS Codon Optimization Technology (DNA2.0) and Cytovance® Biologics' Keystone Expression System™, research cell bank production, process development, process optimization using statistical Design-of-Experiments (DoE), technology transfer, scaled-down model ...
by:Ardena Holding NV based inMariakerke, BELGIUM
The physico-chemical characterisation of your drug substance is the basis of a successful development program. Navigating through the pre-clinical phase is not an easy task. Many compounds fail in early phase development because they are not bioavailable. It is our job to use our pre-formulation development expertise to give your molecule the ...
Manufactured by:RoosterBio, Inc. based inFrederick, MARYLAND (USA)
The path to IND approval for cell-based therapies can be challenging and time consuming with strict regulatory requirements. That is why RoosterBio provides Process Development Services to help you build clinical phase appropriate cGMP processes for your specific product needs. We have served many customers to streamline the path to clinical ...
by:Tjoapack Netherlands B.V. based inEtten-Leur, NETHERLANDS
At Tjoapack we expertly navigate the complexities of clinical-phase pharmaceutical supply using our integrated and flexible packaging solutions. Our proven track record of packaging sensitive high-potency parenterals, medical device assemblies and multi-component therapeutic delivery solutions means we’re well placed to help drug developers successfully ...
by:North American Science Associates Inc.(NAMSA ) based inNorthwood, OHIO (USA)
The clinical phase can be the most time consuming, least predictable, most expensive, and most important part of your development effort. So we work smart from the start, saving you time and preventing costly do-overs by optimizing strategies and tools to guide you through. Our clinical experience encompasses a broad range of technologies, ...
Manufactured by:Nexelis based inSeattle, WASHINGTON (USA)
With an extensive track record developing, qualifying, validating, and transferring tests, our dedicated scientists support programs, from early development to clinical Phase ...
by:Patheon Inc. based inDurham, NORTH CAROLINA (USA)
With speed and efficiency, evaluate the properties of your biologic for a clear understanding of the path to Phase I clinical studies and beyond. Patheon gives you access to the full breadth of advanced analytical technologies and preformulation ...
Manufactured by:Quay Pharma based inFlintshire, UNITED KINGDOM
We are extensively involved in developing early clinical formulations and clinical manufacturing of First in Human trials. We can develop a formulation specifically designed to achieve your targets during the crucial first clinical evaluations of your ...
Manufactured by:AB2 Bio Ltd. based inLausanne, SWITZERLAND
AB2 Bio has developed the first and proprietary assay to detect and measure free IL-18 in body fluids, which gives us the capability of identifying diseases associated with free IL-18 levels. The assay could also be used as a companion diagnostic to select patients most likely to respond to treatment with ...
by:Vetter based inRavensburg, GERMANY
Our experts provide the guidance, insight, and Vetter process documentation you need to prepare a Common Technical Document (CTD) for clinical trials of your injectable drug ...
by:Cytel based inWaltham, MASSACHUSETTS (USA)
Every year, sponsors hesitating to use a complex innovative clinical trial design routinely miss opportunities to optimize the speed, savings and probability of success of their clinical trials. Cytel's statistical consultants and data managers work in tandem with sponsors to ensure new medicines move forward with the right study ...
Manufactured by:Sartorius AG based inGoettingen, GERMANY
A more seamless transition into the clinic. Complex biopharmaceuticals and advanced therapies can present challenges during preclinical development. When implementing an albumin-based solution, Albumedix can help avoid unnecessary complications in your preclinical testing by creating species-specific recombinant albumins to suit your preclinical models. ...
Manufactured by:BioSensics LLC based inNewton, MASSACHUSETTS (USA)
BioSensics provides global operations services to optimize the delivery of BioSensics’ solutions throughout all phases of clinical studies and trials. Our experienced team delivers exemplary service and novel technology to improve data quality and save ...
Manufactured by:Forge Biologics, Inc. based inGrove City, OHIO (USA)
Plasmid DNA is an essential component of gene therapy development and the starting point of Forge’s idea-to-impact manufacturing services to accelerate gene therapy programs from preclinical through clinical and on to commercial manufacturing. Forge’s plasmid production with single-use systems incorporates seamlessly into our optimized AAV manufacturing process for increased ...
by:HingeClinica based inPrinceton, NEW JERSEY (USA)
Our Clinical Data Management team has solid experience in Phase I to Phase IV clinical data management services. We are committed to providing the highest data quality, integrity, and security for our clients in meeting 21 CFR part 11, GAMP 5 and HIPAA requirements. Using industry-leading electronic data capture (EDC) ...