Blog

Clinical Operations

Our Clinical Operations staff, including clinical research managers (CRMs), clinical research associates (CRAs), medical writers (MWs) and clinical trial assistants (CTAs), constitutes the backbone of all our studies regardless of whether we use our own clinics or external sites. 

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

Together the Clinical Operations team members have an average of 10+ years’ experience from the pharmaceutical industry, CROs, healthcare and academia in terms of development and use of pharmaceutical products, medical devices and functional food. 

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. 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 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 drugs and medical devices throughout the products’ life cycles by the detection, collection, assessment and management of adverse reactions or effects. 

Our Pharmacovigilance department has experience of investigational medicinal products, advanced therapy medicinal products (ATMP) and medical devices in a wide range of indications and areas of use. 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 Monitoring, Safety Management, Medical Coding, Safety Committees and Medical Device services within our Pharmacovigilance department. 

 Cornelia Lif-Tiberg, MD, Director Pharmacovigilance

Read more about Cornelia Lif-Tiberg

Biometrics

Our Biometrics team consists of eCRF Managers, Statistical Programmers and Biostatisticians who provide various services over the course of your study.  

Prior to study start, our Biostatisticians give input to the study design, objectives and endpoints and perform sample size calculations. They write or review the statistical sections of the study protocol with the aim of optimising the study output. Read more about our biostatistical services.  

Our eCRF Managers create a fit-for-purpose eCRF that reflects the study protocol and that allows for collection of all necessary study data. Read more about our eCRF and data management services.  

During the study, our eCRF Designers and Statistical Programmers cover all aspects of Data Management- from centralised monitoring support to database-lock and associated clean file documentation. Read more about our statistical programming services.  

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

We validate clinical study data by using Pinnacle 21 Enterprise. The tool verifies that data packages comply with CDISC standards (SDTM, ADaM and SEND), controlled terminology, and dictionaries like MedDRA and WHODrug. 

 Eva JacobssonDirector Biometrics

Read more about our pharmacokineticists

DMPK and Clinical Pharmacology

Our senior advisors offer 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 publications, scientific advice meetings and due diligence assessments 
  • Experience in small molecules, peptides, therapeutic proteins, ATMPs, oligonucleotides and radiopharmaceuticals 
  • Integrated non-clinical support available together with CTC’s sister companies RegSmart Life Science AB, Toxicology Knowledge Team Sweden AB (TKT), Lablytica Life Science AB and MetaSafe AB

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 in, and preparation of data for, meetings with regulatory authorities 
  • Design of FIH studies with adaptive design and dose setting 
  • Production of interim reports based on of blinded data and participation in regular safety committee meetings in dose escalation studies 
  • PK and PK/PD calculations (WinNonlin), modelling 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 

Read more about our pharmacokineticists.