CRO is the acronym for Contract Research Organization. A CRO plans, conducts and reports clinical trials of drug candidates for the pharmaceutical industry.

In phase I trials, drug candidates are tested in healthy volunteers. In phase II trials, drug candidates are tested in small groups of patients who have the disease targeted by the drug.

A drug candidate is a pharmaceutical or biological compound that is not yet registered as a drug and is therefore not yet marketed as a treatment for a given disease.

Clinical trials of drug candidates must be conducted in cooperation with an independent doctor who is responsible for the trial. Very few pharmaceutical companies maintain their own clinics for phase I trials. The pharmaceutical and biotech industries outsource clinical trials so they incur costs for clinical development only when these trials are necessary – and so they can start clinical trials whenever necessary. Outsourcing thus provides efficiency advantages in terms of both time and money.

Our unique location at Hvidovre University Hospital gives us easy access to specialists, special examination modalities and patients. We also provide the highest possible level of safety, with a hotline to the intensive care unit, located right next to us.

All drug candidates must be tested in clinical trials to be approved as new drugs. In early clinical development, from phase I to early phase II, drug candidates are tested for safety, tolerability and efficacy.

It is absolutely crucial that clinical testing of new drugs take place in a safe environment with high quality standards, and that those tests provide the utmost safety both for healthy volunteers and for patients participating in the trials. Convenient, quick access to emergency treatment and specialists is vital.

Before a drug candidate is introduced for treatment of a disease, it is of utmost importance to acquire exhaustive knowledge about the uptake and discharge of the drug candidate in the normal human organism, and to investigate how the drug affects the normal human body.

If necessary, subjects can be referred for treatment at the hospital within minutes. All PhaseOneTrials studies are conducted by an experienced and specially trained team of doctors, nurses and laboratory technicians. We utilize standard procedures for all trials and maintain a 24-hour medical backup for the safety of all participants. Furthermore, we have a 24-hour hotline to the intensive care unit at the hospital.

Experienced doctors who are trained to conduct clinical trials are responsible for clinical trials at PhaseOneTrials.

An experienced PhaseOneTrials project manager communicates directly with the client and conducts the trial according to the trial protocol.

Subjects exposed to new drugs must be observed at regular intervals. These observations may include blood tests around the clock. Furthermore, subjects must often fast for several hours and abstain from coffee, alcohol or other substances. This often makes it necessary to hospitalize subjects in our clinic during trials to ensure strict compliance with trial protocols.

Healthy people aged 18 and older can participate in a phase I trial. All healthy subjects receive repeated medical examinations and blood tests to ensure they can participate in the trials without risk.

Patients who have the disease the drug candidate targets can participate in phase II clinical trials.

PhaseOneTrials screens all potential subjects before they are included in our database. This screening includes a telephone interview, a medical examination and blood tests.

Volunteers receive a full medical examination at no cost and also receive reimbursement for their inconvenience and loss of earnings. This reimbursement varies according to the length of hospitalization and according to other requirements for examination, as well as for complying with special protocols. Reimbursement must always be approved by the Regional Independent Ethics Committee.

Patients participating in phase II clinical trials have the opportunity of being treated with a new drug, and thus the possibility of improvements relative to their disease. They are also monitored closely by medical specialists throughout the trial. Furthermore, their participation may help future patients receive better treatment. If treatment of very short duration makes it unlikely that the patient will benefit significantly, the patient may also be remunerated in the same way as healthy subjects.