Contract research organization - FAQ

A contract research organization (CRO) is a company like Scandinavian CRO (SCRO) that is contracted by pharmaceutical, medical device and other biotech companies to perform research services. SCRO is a full-service CRO that conducts clinical research, from carrying out clinical trials and post-marketing studies to developing clinical development and post-marketing strategies. In addition to supporting pharmaceutical and medical device companies, SCRO also works with researchers and doctors from academia and the healthcare sector to carry out investigator sponsored studies, enabling them to translate their research ideas to the clinic and improve future health.

ADE=Adverse Device Event

AE=Adverse Event

AS=Active Substance

ASADE=Anticipated Serious Adverse Device Event

ASCRO=Swedish Association of Contract Research Organizations

ATC= Anatomical Therapeutic Chemical code

ATMP=Advanced Therapy Medicinal Product

b.i.d.=Twice a day

BLA=Biologics License Application

BMI=Body Mass Index

BSC=Biological Safety Cabinet

CAPA=Corrective Action/Preventative Action

CAS=Chemical Abstracts Service chemical ID number

CAT=Committee on Advanced Therapies

CBER=Center for Biologics Evaluation and Research

CCI=Commercially Confidential Information

CDA=Confidentiality Disclosure Agreement

CDD=Clinical Drug Development

CDER=Center for Drug Evaluation and Research

CDISC=Clinical Data Interchange Standards Consortium

CE= “Conformité Européene” (European Conformity); CE-marking

CER=Clinical Evaluation Report

CF=Clean File

CHMP=Committee for Medicinal Products for Human Use

CGT=Cell and Gene Therapy

CI=Confidence Interval

CIOMS=Council for International Organizations of Medical Sciences

CIP=Clinical Investigation Plan

CIR=Clinical Investigation Report

CMC=Chemistry, Manufacturing & Control

COA=Certificate of Analysis

COV=Closeout Visit

COM/CPM=Clinical Operations Manager/Clinical Project Manager

CPMP=Committee for Proprietary Medicinal Products, now called CHMP

CQA=Critical Quality Attribute

CPE=Cytopathic Effect (IU)

CPP=Critical Process Parameters

CPSP=Clinical Performance Study Protocol

CPSR=Clinical Performance Study Report

CRA=Clinical Research Associate (CRAs perform clinical monitoring)

CRF/eCRF=Case Report Form/electronic Case Report Form

CRO=Contract Research Organization

CSP=Clinical Study Protocol

CSR=Clinical Study Report

CTA=Clinical Trial Agreement, Clinical Trial Application or Clinical Trial Assistant

CTD=Common Technical Document

CTF=Central Technical Facility

sCTMP=somatic Cell Therapy Medicinal Product

CTOM=Clinical Trial Operating Manual

DCF=Data Clarification Form

DD=Device Deficiency

DMC=Data Monitoring Committee

DMP=Data Management Plan

DVP=Data Validation Plan

DP/DS=Drug Product/Drug Substance

DSMB=Data Safety Monitoring Board

DSUR= Drug Safety Update Report

EDC=Electronic Data Capture

EMA=European Medicines Agency

EudraCT=EU database on Clinical Trials

EV or EVMPD=EudraVigilance Medical Products Dictionary

FAS=Full Analysis Set

FDA=Food and Drug Administration

FIH=First-in-Human

FPFV=First Patient First Visit

FPI=First Patient In

GCP=Good Clinical Practice

GDP=Good Documentation Practice

GLP=Good Laboratory Practice

GMO/GMM=Genetically Modified Organism/Microorganism

GMP=Good Manufacturing Practice

GNA=Grounds for Non-Acceptance

HRQL/QoL=Health-Related Quality of Life/Quality of Life

IB=Investigator’s Brochure

ICD-10=International Statistical Classification of Diseases and Related Health Problems – Tenth Revision

ICF=Informed Consent Form

ICH-GCP=International Conference on Harmonisation Guidelines for Good Clinical Practice

IEC/IRB=International Ethics Committee, Institutional Review Board

IND=Investigational New Drug

i.m.=Intramuscular

IMPD=Investigational Medicinal Product Dossier

IMP/IMD/IP= Investigational Medicinal Product/Investigational Medical Device/Investigational Product

INN=International Non-Proprietary Name

i.p.=Intraperitoneal

IPC=In-Process Controls

IRT/IWRS=Interactive Response Technology/Interactive Web Response System

ISF=Investigator Site File

ISO=International Organization for Standardization

ISRCTN=International Standard Randomised Controlled Trial Number

ITT=Intention-to-treat population

i.v.=Intravenous

IVD=In Vitro Diagnostic Medical Device

IVDR=In Vitro Diagnostics Regulation

IVRS=Interactive Voice Response System

LIF=Läkemedelsindustriföreningen (Swedish Association for the Pharmaceutical Industry)

LPLV=Last Patient Last Visit

LPO=Last Patient Out

MA/MAH=Marketing Authorisation/Marketing Authorisation Holder

MCB/WCB=Master Cell Bank/Working Cell Bank

MDR=Medical Device Regulation

MedDRA=Medical Dictionary for Regulatory Activities

MOA=Mechanism-Of-Action

MOOSE=SCRO’s Project Management Model (Modern, Ongoing, Optimal, Sustainable, Efficient)

MOV=Monitoring Visit

MTD=Maximum Tolerable Dose

MVS=Master Viral Seed

NB=Notified Body

NCA, CA, or MS CA=National Competent Authority, Member State Competent Authority

NDA=New Drug Application

NIS=Non-Interventional Study

PER=Performance Evaluation Report

PFS=Progressive Free Survival

PI=Principal Investigator

PIP=Paediatric Investigation Plan

PK/PD=Pharmacokinetics/Pharmacodynamics

PMCF=Post-Market Clinical Follow-Up

PMPF=Post-Market Performance Follow-Up

PMS=Post-Market Surveillance

PMSR=Post-Market Surveillance Report

p.o.=Peroral

PPA=Per Protocol Analysis Population

PPD=Protected Personal Data

ePRO/PRO=electronic Patient Reported Outcome

PSUR=Periodic Safety Update Report

PSV=Pre-Study Visit

PV=Pharmacovigilance

QA=Quality Assurance

QC=Quality Control

q.d.=Once a day

QMS=Quality Management System

QoL=Quality of Life

QP=Qualified Person

RA=Regulatory Authorities (could also refer to Regulatory Affairs)

RBM=Risk-Based Monitoring

RCA=Replication Competent Adenovirus

REC=Regional Ethics Committee

RoA=Route of Administration

R-RCT =Registry-Based Randomized Clinical Trial

SADE=Serious Adverse Device Event

SAE=Serious Adverse Event

SAP=Statistical Analysis Plan

s.c.=Subcutaneous

SCRO=Scandinavian CRO

SD=Standard Deviation

SD/PD=Stable Disease/Progressive Disease

SE=Standard Error

SDV=Source Data Verification

SIV=Site Initiation Visit

SmPC/SPC=Summary of Product Characteristics

SOC/PT=System Organ Class/Preferred Term (MedDRA)

SOP=Standard Operating Procedure

SUSAR=Suspected, Unexpected Serious Adverse Event

TEP=Tissue Engineered Product

TMF=Trial Master File

USADE=Unanticipated Serious Adverse Device Event

VMB=Viral Master Bank

WHODRUG=World Health Organization Drug Dictionary

High-quality and compliant Phase I to Phase III clinical trials are critical for obtaining market approval of a drug or biologic. After the product is approved for market, post-marketing surveillance and post-marketing studies are performed in order to gain a deeper understanding of its safety and efficacy profile.

Phase I clinical trials

Are you ready to test your research idea in a proof-of-concept (POC) Phase I clinical trial? Is it time for a first-in-human trial to investigate the pharmacokinetics (PK) of your IMP in healthy, paid volunteers? Phase I clinical trials typically consist of a small number of subjects to test safety, pharmacokinetics, and possibly multiple doses. In oncology studies, a small number of patients are treated and the study may be a combined Phase I/Phase II clinical trial to investigate both efficacy and safety.

Phase II clinical trials

Phase II clinical trials investigate the efficacy and safety of the investigational drug or biologic, typically in up to a few hundred patients. Phase II clinical trials may be randomized, and the choice of whether to use a comparator or placebo for the control group is critical and can make or break the study. Indeed, the choices made regarding study design, blinding, control group, sample size and endpoints are all crucial and need to be based on previous experience, published data, and regulatory recommendations.

Phase III clinical trials

Phase III clinical trials usually include hundreds or even a few thousand patients in a randomized trial. The Phase III clinical trial is referred to as a pivotal study if the trial intends to provide unambiguous, evidence-based data confirming efficacy and safety that will be used to submit an application for market approval to the regulatory authorities. Because Phase III clinical trials are of pivotal importance for gaining market approval, it is crucial to have a clear clinical development strategy based on the market and regulatory landscape in order to get it right from the start.

Phase IV clinical trials

Phase IV clinical trials, or post-marketing studies, are performed after the product has been approved for market and can identify serious and/or unexpected signals of risk that may have been previously undetectable during clinical development due to a relatively small number of treated patients. Post-marketing studies may even be recommended by regulatory authorities to study a specific subpopulation of patients or to further assess product quality. Ultimately, the knowledge gained from post-marketing studies is used to increase patient safety and achieve a better understanding of the product’s benefit-risk profile.

Interventional trial: participants receive a study-specific intervention (e.g., treatment, procedure, medicine, etc.).

Observational trial or non-interventional trial (NIS): no new intervention (e.g., treatment, procedure, medicine, etc.) is introduced into the subject’s care. During this type of study, the subject’s routine care is observed and the real-world data is collected and analyzed.

Randomized clinical trial: participants are randomized into different treatment groups, such as a control group and a test group. The control group may receive placebo or a comparator (i.e., standard treatment). There may be several test groups, for example to test different doses of the investigational product.

Registry-based randomized clinical trial (R-RCT): Sweden is a pioneer in this area, which combines the power of national clinical registries with the rigor of randomized clinical trials.

Pharmaceutical drug: a substance intended to diagnose, prevent, or treat a disease, or modify physiological functions, through pharmacological action.

Medical device: a device or reagent intended for diagnosis, monitoring, treatment or prevention of a disease or condition. Medical devices can also support, modify or replace parts of the anatomy or physiological processes. In Europe, there are four classes of medical devices.

In vitro diagnostic (IVD) medical device: a medical device (i.e., device or reagent) that is intended to diagnose, monitor, prevent or treat a disease or condition by in vitro testing of human specimens (e.g., urine, blood, tissue, etc.). In Europe, there are four classes of IVDs.

Advanced therapy medicinal product (ATMP): a new generation of biologics including gene therapy, cell therapy and tissue engineering products.

Combination products: Products that combine drugs, medical devices and/or biologics.