BE Studies

Pkinetix BA/BE Services:

Pkinetix provides a wide range of services for Bioequivalence and Bioavailability studies. We can help our clients design and conduct their studies successfully through the following services:

• Recruitment: Recruiting is crucial to the clinical trials process. Our effective approach to recruitment includes study specific recruitment strategies to ensure that our panels are filled as quickly and efficiently as possible. The success of our recruitment programs are based on several factors including:
• • an enrollment process that follows inclusion and exclusion criteria specifically identified in the study protocol,
  • a database of hundreds of pre-screened healthy volunteers and patients suffering from specific illnesses and
  • a large network of specialist doctors allowing us easier access to target patient populations, when they are needed.

• Clinical Services: Our clinical facilities have over one hundred beds with fully equipped Clinical units in Chile, Uruguay, Argentina and Brazil. We also have a fully GCP/GMP compliant pharmacy, ensuring the complete chain of drug custody from reception to final accountability, as well as appropriate licensing to handle and import controlled substances. We have an experienced group of Investigators committed to the health, safety and well-being of the study participants. Our dedicated medical safety team reviews, assesses and monitors any adverse events or serious adverse events in order to ensure safety and shorten timelines from data collection to clinical report. We include study coordinators assigned to each study to provide fast and efficient updates of the trial status to sponsors and collaborators.

• Bioanalytical Services: Our bioanalytical facilities are fully equipped with GLP-compliant and state-of-the-art instrumentation including the latest MS-MS spectrometers and liquid crystallography equipment and are used for complex studies such as metabolite identification and protein and peptide quantitation. Our scientific expertise allows us to provide method development and validation using strict criteria as well as analysis of parent drugs and multiple metabolites from various biological matrices. Sample analysis is performed by employees highly trained in GLP and international regulations ensuring straightforward and compliant submission of bioanalytical results for any country.

• Statistical Services: Our team provides a wide range of statistical services. These include study design process (sample size calculation, endpoint definitions and statistical methodology), statistical analysis plans (patient populations, parameters for analysis and primary and secondary endpoints), clinical data review (primary efficacy parameters and standard safety data review), study-specific safety and efficacy data tabulations (with data summaries in-line with ICH requirements outlined in E3) and statistical analysis with data listings and preparation of summary tables . Finally, our medical writers ensure that draft and final reports are produced meet the highest quality standards.

• Regulatory Affairs: Our Regulatory Affairs team is involved in regulatory assistance to ensure that the goal of your study meets the requirements of corresponding authorities. As the conduct of clinical research is closely linked to health authority guidelines, our regulatory team provides pharmaceutical companies with proper understanding and comprehension of Latin America regulatory environments and frameworks (regulatory issues from different local authorities: ANMAT, ANVISA, ISP, COFEPRIS). The Regulatory team provides customized clinical trial reports carefully prepared as per the most stringent international guidelines (FDA, EMA, Health Canada and SFDA).

• Quality Assurance: Our dedicated Quality Assurance team provides an audit program which covers the requirements of regulatory authorities in relation to good practices that apply to the highly regulated pharmaceutical industry. Good Clinical Practice, Good Laboratory Practice, and Good Manufacturing Practice quality systems are applied across our different services: the facilities, equipment, personnel, methods, practices, records and controls are all compliant with protocols, SOPs, applicable guidelines and regulations. Our program ensures that we maintain our excellent track record and continue to operate to the standards required by the regulatory authorities in each country.

• Medical Writing: Our team of professional medical writers provides a complete writing service to clients. This service includes preparation of protocol, protocol amendments, CRFs, clinical study reports, pharmacokinetic reports, safety reports and any other document necessary for the successful running of the trial. All documents will be tailored to individual requirements and produced to the applicable regulatory guidelines.