Life sciences consulting experts are an ideal way for a company to prepare for a clinical trial in the health sciences. Before a medical device, medication or technique can be released to the general public, regulatory experts require that clinical trials take place. This helps to ensure the safety of the participants and the general public. Consider these four ways that life sciences consulting professionals help with the advancement of this important aspect of drug and device development.
Evaluating Quality of the Devices or Drugs
Consulting firms are able to perform quality assurance testing on devices. This might involve taking measurements or conducting robotics testing to see how long a device can be used until it needs maintenance or fails. Another aspect of quality assurance testing is checking production lots of a medication. This is done in order to ensure that each dose of the medication has the specified amount of the active ingredient. While medications might have a range within a specified amount of error, the medication must have consistent dosing for effectiveness and safety purposes.
Assessing Toxicology Data
Consulting firms are also able to assess toxicology data. Some information might already be available about the toxicity of a medication. The consultants can use that information to help determine the proper dosage for a patient based on the patient’s symptoms. Another aspect of toxicity is the amount of the drug that the patient can take before unwanted side effects become common. For example, if a drug causes unwanted side effects in 5 percent of people at a 0.1 milligram dose and 50 percent of people at a 0.5 milligram dose, the desired dose of the drug might be set at 0.1 milligrams to maximize benefits and minimize side effects.
Auditing of Participant Data
Auditing of participant data is also important to the clinical trials process. If the clinical trial is consisting of a control group and a treatment group, the data could be used to ensure that the two groups are as similar as possible. Consultants might also want to look at participant data and side effects. For example, the consultants might discover that people with a body mass index greater than 35 experience side effects at a higher rate than people with a body mass index of 30 to 34.
Assessing Patient Outcomes
Regulatory experts also want to assess patient outcomes as part of clinical trials. In the health sciences, a new medication might be as effective as an existing drug, but it causes fewer side effects. This is important to the drug discovery process and can advance medical treatment for people who need it.
