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Monday 10:00 - 18:00 Tuesday 10:00 - 18:00 Wednesday 10:00 - 18:00 Thursday 10:00 - 18:00 Friday 10:00 - 18:00

Paspigioni

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Paspigioni

Clinical Research Organisation that provides support to pharmaceutical and biotechnology companies in conducting clinical trials.

13/01/2023

How can the success of clinical partnerships be measured?

Measuring the performance of a particular partnership is not always easy. Which metrics and KPIs should be tracked to judge not just the performance of the CRO, but the performance of the combined effort?

One of the most critical pieces of the combined effort is agreeing upfront on a realistic (and not too ambitious) plan regarding milestones and timelines (and cost). The performance of the partnership can then be assessed by measuring whether the actual figures meet the plan with regards to Time, Budget and Quality. But this makes sense only if the plan was realistic in the first place.
Relationship KPIs include data such as data currency, completeness and quality, protocol deviation/violation but also costs difference between initial agreed budget and final one.
There are a number of approaches that could be used. This can be used to provide a measure of the opinion across the partnership of how well it is working and could be monitored over time to establish any trends.

11/10/2022

In part 2, we focused on the following protocol sections that require us to stop and think about research ethics.
1. Inclusion/ Exclusion Criteria
2. Safety and Efficacy Endpoints
3. Staff credentials and training
4. Schedule of Events
5. Medication Compliance
6. Lost to Follow-up
7. Patient Discontinuation
8. Early Trial Termination
9. Medical Emergency
10. Amount and Type of Data Collection
11. Operational Instructions
12. Continuation Protocol
13. Committees in Multicenter Trials
14. Data Confidentiality
15. Publications
As a general rule of thumb, always remember what matters most to regulatory authorities and ethics committees are patient safety, patient privacy and whether benefits to patients outweigh the risks. When dealing with ethical considerations, your goal should be to keep the regulatory perspective in mind at all times.

If you have any question or comment on ethics in research, please let us know by leaving a comment below.

31/08/2022

Here’s What’ve Covered on Clinical Research Ethics
In part 1, we covered the following ethical questions you need to ask when developing a clinical trial strategy.
1. Is there a need for a clinical trial?
2. Is it ethical to include a placebo treatment group?
3. Is your choice of an active control acceptable?
4. Has the clinical trial eliminated obvious bias and deception?
5. Has sufficient attention been given to sample size?
6. Is the statistical power of a trial adequate to demonstrate efficacy i.e. medical treatment effective?
7. What is the safety of the patients enrolled in the clinical trial?
8. What is the safety of the patients enrolled in the clinical trial?
9. What types of patients are to be entered into a clinical trial?
10. What should patients be paid for their participation?

26/07/2022

13. Committees in Multicenter Trials
For multi-center studies, centralized committees are generally ongoing clinical data monitoring.
For example, certain medical device clinical studies may be required to appoint a Data Safety and Monitoring Board for patient safety.
During the course of the trial, if this committee is concerned about the data being collected, it has the authority to ask the Sponsor to stop or pause the trial due to ethical and patient safety concerns.

23/07/2022

12. Continuation Protocol
There may be a lag between trial completion and regulatory review of the clinical data. During this period, the Sponsor may decide to implement a continuation protocol. One objective of a continuation protocol is to ensure that the patients have access to the trial drug after trial completion. For device trials, the Sponsor may want to collect additional safety and efficacy data while the trial data is under regulatory review.For control patients, the question arises whether they should be receiving the trial drug or device, while the regulatory review is underway. This sought of ethical concern needs to be clearly thought through when designing a continuation protocol.

04/07/2022

We are proud of our clinical researches expertise! Together we are capable of managing all kinds of projects in the pharmaceutical and medical device industries. Depending on your needs and requests we will create a dedicated team that is capable of managing your entire project. Just one stop to get all the experience you are looking for.

23/05/2022

10. Amount and Type of Data Collection
Once enrollment commences, clinical data needs to be collected and entered in the case report forms.If the amount of clinical data being collected is vast, researchers may end up with a partially complete dataset at the time of analysis.
Missing or incomplete can pose a serious issue to provide the scientific value of the trial. Conversely, if the trial fails to collect the required critical fields, the scientific community will find it difficult to accept or interpret the trial results.

11. Operational Instructions
Operational instructions to patients such as consent form and procedure brochures must be reviewed and approved by the ethics committee. Patients must also be provided clear instructions on whom to contact in case of an emergency or follow-up questions after their visit. Aside from patient instructions, sites must have access to Sponsor name and contact information when dealing with a medical emergency.

04/04/2022

We are deeply worried about the current situation in . We are adapting our plans in line with constantly changing circumstances.
We want nothing more than everybody to live in peace and safety, and hope for this war to end as soon as possible.

18/02/2022

9. Medical Emergency
In the case of a medical emergency, the site must be able to contact the Sponsor safety representative to discuss the adverse reactions and potential treatment.
In double-blinded protocols where the patient and the investigator do not know the treatment arm, a process must be established on how the blind will be broken in case of an emergency.

29/11/2021

8. Early Trial Termination
Some clinical trials may end earlier than expected.
Reasons for stopping studies early include positive or negative results, extremely slow enrollment, protocol non-compliance, and research staff changes. If positive results are discovered during an interim analysis of a randomized control trial, it may become ethically necessary to provide control patients with the new device or drug.
If negative results such as higher than anticipated rate of serious adverse events can lead the trial being terminated early. Some studies are extremely slow to enroll due to extremely tight inclusion and exclusion criteria or lack of commitment from the research staff. For slow enrolling trials, it may be necessary to terminate the trial early and transfer enrolled patients to another nearby site for their safety.
If major audit findings such as protocol non-compliance are discovered, the regulatory agency or Sponsor may decide to stop the trial early. All these scenarios require careful planning for successful protocol design and trial conduct.

16/11/2021

7. Patient Discontinuation
When a patient experience a serious adverse event, the patient may choose to discontinue from the clinical trial.
However, it is the site investigator’s responsibility to ensure the patient is safe and receives the necessary medical care after such discontinuation.
In some situations, the patient may decide to join the trial again after discontinuation. If this happens, it would be necessary to re-consent the patient.

25/10/2021

5. Medication Compliance
It is not uncommon for trial patients to be sent home and asked to take medications as per trial protocol.
However, medication compliance can vary greatly among patients.
Some patients may be disciplined and follow the doctor’s instructions. Others may forget to take their medication or choose to ignore the doctor’s instructions.
In order to ensure medication compliance, clinical trials may have monitoring systems to randomly check patient adherence to the trial protocol.
This type of monitoring can have an impact on patient privacy. For this reason, it is important to include any such monitoring systems in the informed consent form.
6. Lost to Follow-up
Is it acceptable to contact the patient for additional information related to their participation in the trial after he or she is considered “lost to follow-up”?
Protocols usually include a definition for patients lost to follow-up.
For example, if a patient misses two consecutive visits, the patient may be considered lost to follow-up. The ethical question is whether the patient can be contacted after they have been flagged as lost to follow-up. Also, data collection can be inconsistent across sites if the protocol lacks a clear definition of lost to follow-up.
For example, sites may be required to make three attempts to get in touch with the patient before her or she is considered lost to follow-up.
If all participating sites are not trained on follow-up requirements, patient follow-up compliance rates can vary greatly amongst sites.

Address

Irakli Abashidze Str. 86, App . 34
Tbilisi
0179

Opening Hours

Monday	10:00 - 18:00
Tuesday	10:00 - 18:00
Wednesday	10:00 - 18:00
Thursday	10:00 - 18:00
Friday	10:00 - 18:00

Telephone

+995568828174

Website

https://paspigioni.com/

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