Clinical Services

Clinical Services

Phase I/II

With facilities in both the US and Canada, Altasciences Clinical Research offers comprehensive Phase I/II drug development, including all required support services.

We offer quality solutions to pharmaceutical, biotechnology and generic drug companies across the world, with a focus on customer service.

We also offer several specialized areas of expertise.


We have more than one hundred dedicated bioanalytical scientists working with the latest equipment to ensure compliant and on-time regulatory submissions. We provide bioanalytical support for all stages of drug development from preclinical studies (non-GLP and GLP) through all phases of clinical development (Phase I-IV) for both small and large molecules.
View our validated Bioanalytical Assay List


Given the resource efficiency option available through the 505(b)(2) pathway, many sponsors are working towards this application. We offer a  comprehensive solution, covering all requirements when working towards a 505(b)(2) submission. This includes our input in early stage study design, liaison with the FDA to ensure the protocol will meet 505(b)(2) criteria, clinical study conduct and reporting.


As a global player in early stage clinical trials and bioanalysis, we provide a wide range of services for bioequivalence and bioavailability studies from study design to study conduct and study reporting.


Our dedicated teams of data managers, biostatisticians and statistical programmers have extensive experience in collaborating with clinical teams, from small biotechnology companies to large pharmaceutical corporations, and everything in between. We offer biostatistics, statistical programming, CDISC implementation and data migration as well as clinical data management services. Our guidance and navigation through the complex, global clinical research landscape ensures consistent and cohesive clinical development programs.


We are committed to consistently providing our clients with the highest quality regulatory support in order to meet key clinical trial milestones and ensure that study goals meet the requirements of corresponding authorities. Our experienced regulatory team offers: IRB submission, preparation of pre-CTA and pre-IND packages, coordination with the regulatory agency for pre-CTA/IND meetings, CTA preparation, submission to Health Canada as well as negotiation and Clarifax responses.


Patents for several innovator biologics blockbusters, primarily monoclonal antibodies, will expire in the next few years. Driven by biopharmaceutical companies’ needs to diversify their product portfolio as well as create new revenue streams, the development of biosimilars is expected to grow substantially over the coming years. It has been reported that the average estimated cost for developing a biosimilar could range between $75 and $250 million USD