Phase I/IIa

With access to an extensive database of healthy, patient and special populations, Algorithme Pharma's comprehensive full service Phase I/IIa offering provides sponsors with high quality trial conduct, Therapeutic class expertise, as well as accelerated study-start and report timelines.

Our customized study designs include :

  • Efficacy / Proof of Concept (POC) studies
  • First in Human (FIH)
  • Single ascending dose (SAD) and multiple ascending dose (MAD)
  • Adaptive Integrated Clinical Designs (SAD/MAD)
  • Safety and tolerability in healthy volunteers, selected special populations and patient groups
  • Food effect, Age effect, Gender effect, PK/PD
  • QTc studies
  • Drug/Drug Interaction studies
  • Bioequivalence and comparative Bioavailability studies
  • Biological/Biosimilars
  • 505(b)(2)
You may also be interested in our cognitive testing expertise.
First-In-Human (FIH) Trial Gantt Chart Customize, view, print and email it. Click here to try the tool >>

Recruitment

Recruiting is crucial to the clinical trials process. Our effective approach to recruitment is two-fold.

Clinic

We have 25 years of experience conducting clinical trials. Our Montreal, Québec, clinic has 265 beds, while our Fargo, North Dakota, clinic (under the leadership of Dr. James Carlson) has access to 200. The beds are located in fully equipped clinical units, including a dedicated long-stay unit.

Data Management

We deliver comprehensive data management services using efficient and meticulous processes, coupled with state-of-the-art technologies.

Project Management

High quality project management is key to the success of a clinical trial.

Regulatory Affairs

Our Scientific & Regulatory Affairs Department is involved in regulatory discussions to assure that the goal of your study meets the requirements of corresponding authorities.

Bioanalytical Services

The Bioanalytical Services Department offers scientific excellence, uncompromised quality and unbeatable timelines to meet and exceed client needs.

Quality Assurance

We are committed to the provision of accurate, rapid and reliable results.

Medical Writing

We have developed a strong reputation for delivering a high quality, reliable and responsive medical writing service. Our dedicated team of professional medical writers provides a complete writing service to clients around the globe...

Pharmacokinetics and Pharmacodynamics

Our team provides extensive pharmacokinetic (PK) and pharmacodynamic (PD) support in preclinical and clinical studies.

Scientific Affairs

Once your needs have been clearly identified, the Scientific & Regulatory Affairs Department will prepare a study design that best accommodates development needs and effective study conduct.

Biostatistics

Our Biostatisticians and Statistical Programmers provide you with high quality statistical services, in accordance with regulatory requirements.

Clinical Sample Kits & Management Support

Preparing, collecting and shipping clinical samples from trial sites to bioanalysis laboratories is a critical support service when managing clinical programs.