Clinical Services

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.

Bioanalysis

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.

505(b)(2)

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.

Bioequivalence

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.

Biometrics

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.

Regulatory

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.