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Clinical Operations

Clinical Operations at CTC provides key functions in all our studies regardless of whether we use our own clinics or external sites.

Our Clinical Operations team consists of Clinical Research Managers (CRMs), Medical Writers (MWs), Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs) who coordinate each project from clinical study protocol development to clinical study report writing.

With a customer-focused and flexible approach, the CRMs coordinate multiple internal deliverables in full-service as well as part-service projects and are ready to solve any challenges that arise during a study.

Our professional teams apply their operational expertise to ensure proper planning, conduct and reporting of each trial, always with data quality and patient safety in mind and in compliance with ICH-GCP/ISO 14155, SOPs, guidelines, policies and best practices.  

Together the Clinical Operations team members have an average of 15+ years’ experience from the pharmaceutical industry, CROs, healthcare and academia in the development and use of pharmaceutical products, medical device and functional food.

Our Clinical Research Managers (CRMs) provide leadership and operational expertise through collaborative planning and execution, of Phase 0 to Phase II studies. They skilfully manage vendors and study teams to ensure effective start-up and regulatory compliant conduct of your clinical trial in close collaboration with each customer. Read more about our project management services.

Our Clinical Research Associates (CRAs/Study Monitors) continuously interact with the sites, supporting each Investigator to maximize quality, performance and CSP adherence. They identify, assess, monitor and mitigate risks that could affect the safety of the subjects or the quality of each clinical trial. Read more about our CRA and CTA services.

Our Clinical Trial Assistants (CTAs) thoroughly manage the Trial Master File to keep it inspection-ready and support the project teams in their day-to-day activities.

Our Medical Writers (MWs) proactively coordinate the cross-functional development of clinical study protocols and effectively and clearly analyse and communicate the clinical output from your study, orally and in writing. Read more about our medical writing services.

 Ann-Sofie SvenssonDirector Clinical Operations

Read more about Janet Håkansson, Clinical Research Manager

Pharmacovigilance

Pharmacovigilance is all about safer and more effective use of products throughout the product life cycle by collecting, detecting, assessing and managing adverse effects. Hence, preventing and minimizing the risk of any potential harm that may come to subjects or patients.

CTC’s Pharmacovigilance department encompasses experience with investigational medicinal products, advanced therapy medicinal products (ATMP) as well as medical devices in a wide range of indications and areas of use and the team carries out their work in accordance with good pharmacovigilance practice (GVP) and related regulations and directives.

Every medicinal product and medical device must have a satisfactorily completed clinical trial/investigation program establishing acceptable evidence of safety and efficacy before achieving marketing approval and or CE marking.

Our Pharmacovigilance team can offer full guidance in identifying your company’s specific needs regarding required pharmacovigilance activities, safety management and medical monitoring as well as tailor our services to provide suitable and reliable support to your team throughout the development process.

Read more about Medical MonitoringSafety ManagementMedical CodingSafety Committees and Medical Device services within our Pharmacovigliance department.

 Cornelia Lif-Tiberg, MD, Director Pharmacovigilance

Read more about Cornelia Lif-Tiberg

Biometrics

Our Biometrics team consists of eCRF Managers, Statistical Programmers, Pharmacokineticists and Biostatisticians and will guide you from study design to report. 

Prior to study start, our Biostatisticians assist with selection of endpoints and sample size calculations to ensure that your study meets the target. They write or review the statistical sections of the study protocol with the aim of optimising the study design. Read more about our biostatistical services. 

Our professional eCRF Managers will create a fit-for-purpose eCRF that reflects the study protocol and that allows for collection of reliable data for primary and secondary endpoints. As a flexible and cost-effective partner, we pride ourselves in delivering high-quality data in a timely manner. Read more about our eCRF and data management services. 

During the study, our eCRF Designers and Statistical Programmers work with high efficiency in assignments covering all aspects of Data Management – from eCRF design to database-lock and documentation. The Biometrics team also perform randomisations and interim analyses. Read more about our statistical programming services. 

After the study, our Statistical Programmers will display the data in tables, figures and listings as outlined in the statistical analysis plan (SAP) while our Biostatisticians and Pharmacokineticists take part in data analysis and writing of clinical study reports in accordance with agreed timelines.  Read more about our pharmacokinetic services. 

 Eva JacobssonDirector Biometrics

Read more about our pharmacokineticists

DMPK and Clinical Pharmacology

Our senior advisors offers in-house services ranging from compound optimization to proof-of-concept trials, with focus on DMPK and PK/PD.

Non clinical

The non-clinical Drug Metabolism and Pharmacokinetic (DMPK) consultant provides services ranging from compound optimization and selection to First-In-Human (FIH) clinical trial application.

  • Strategic project support regarding compound optimization in drug discovery with focus on DMPK and pharmacokinetics & pharmacodynamics (PK/PD)
  • Design, calculation (WinNonlin) and reporting of non-clinical PK and toxicokinetic (TK) studies
  • Design and interpretation (PKPD) of non-clinical pharmacology studies
  • Project support of clinical trial-enabling studies with focus on PK, PK/PD, TK, drug metabolism, drug-drug interaction (DDI) and bioanalysis
  • Prediction of human PK and human efficacious doses with help of in vivo-in vitro extrapolation, allometry and physiological based-pharmacokinetics (PBPK)
  • Support regarding scientific publication, scientific advice meetings and due diligence assessments
  • Experiences with small molecules, peptides, therapeutic proteins, ATMPs, oligonucleotides and radiopharmaceuticals
  • Integrated non-clinical support available together with CTC’s sister companies Toxicology Knowledge Team, Lablytica and RegSmart

Clinical

The clinical Pharmacologist provides pharmacokinetic (PK) and pharmacodynamic (PD) services ranging from integration of early development PK/PD data to design of the first-in-human (FIH) studies to proof-of-concept trials.

  • Non-clinical support of clinical trial-enabling studies with focus on PK, PK/PD, TK, drug metabolism, drug-drug interaction (DDI) and bioanalysis
  • Predictions of human PK (in vivo-in vitro extrapolation, allometry and physiological based-pharmacokinetics)
  • Summarize non-clinical and clinical PK sections in the IMPD and IB documentation
  • Support, participation and preparation of data for meetings with regulatory authorities
  • Design of FIH studies with adaptive design and dose setting
  • Performance of interim reports of blinded data and participate in regular safety committee meetings in dose escalation studies
  • PK and PK/PD calculations (WinNonlin), modeling and simulation, and reporting
  • Design of metabolites in safety testing (MIST) studies and strategies
  • Design of phase I studies such as bioavailability, bioequivalence, biosimilar, DDI, EPQT, renal and hepatic impairment, human ADME, PET and MRI studies.
  • Design of biomarker strategies and phase IIa studies
  • Microdosing (PET and microdialysis) and local administration of drugs in various organs
  • Full-service studies in dedicated research clinics (including FIH approved clinic) and in-house support services with medical writing, pharmacovigilance, data management and statistics, bioanalysis and QA

Read more about our pharmacokineticists.