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Unlock Big Pharma Opportunities with Good Clinical Practice Certification

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Published - 13.Jun.2024
Unlock Big Pharma Opportunities with Good Clinical Practice Certification

It is plain to see how much the pharmaceutical industry has grown over the past couple of years and how much it is still growing today. What lies at the center of all pharma, however, is maintaining good clinical practice. GCP has become one of the most sought-after standards in the healthcare industry. Without it, most studies would not be properly managed and even allowed to continue forward.

Thanks to this, most companies require their employees, working on clinical trials, to have good clinical practice certification. Without it, employers can’t really be sure their experts understand the responsibilities clinical trials hold and how to act accordingly when necessary at each step of the process. 

Taking a good clinical practice course from an institution that is certified by Transcelerate BioPharma Inc. is one of the first steps towards not only getting an opportunity at a prominent pharmaceutical company but also to the beginning of your career in the industry. 

What is good clinical practice?

To define good clinical practices we have to take a look at the institution that created them – The International Conference on Harmonisation (ICH). They put forward good clinical practice guidelines in order to provide a standardized assurance to companies and the public. This assurance is meant to show that any pharmaceutical product comes from a safe and well-regulated clinical trial.

Good clinical practice principles at their core are meant to ensure accurate and reliable clinical trials as well as the safety of the participants and the public. The reason why good clinical practice training is so important is to instill these fundamental principles of how a trial should be conducted. But what exactly are these principles?

ICH good clinical practice guidelines

Some of the key components of GCP determined by ICH are listed below. This is just a small summary of what a good clinical practice certificate offers as a knowledge base. 

  • Ethical considerations. All trials have to be conducted according to the Declaration of Helsinki. Institutional review boards (IRBs) or ethics committees (ECs) should grant prior approval. Every participant must freely give informed consent.
  • Protocol. A detailed protocol should be prepared and followed. Such a protocol includes the aims, methods, scientific background, statistical considerations, and organization of the trial. All changes to it must be documented. 
  • Investigators. Investigators should be qualified by training and experience. Their responsibilities lie in the correct conduct of the trial and the reliability of the collected data.
  • Trial management, data handling, and record keeping. The basis of trials is standard operation procedures. Collected data must be accurate, verifiable from source documents, and stored securely to prevent accidental or malicious alterations.
  • Sponsor responsibilities. Sponsors are responsible for the overall management of the trial, ensuring compliance with GCP, and handling all regulatory submissions.
  • Clinical trial supplies. Management of drugs or devices under investigation (including procurement, storage, and handling) must ensure that they are of high quality and properly accounted for.
  • Safety reporting. All adverse events reported during the clinical trial must be recorded and reported to relevant parties, including the IRB/EC and regulatory authorities, as required.
  • Quality assurance. To ensure compliance with GCP, quality assurance processes should be applied at every phase of the trial.
  • Audit and inspection. Regular audits should be conducted to ensure compliance with GCP. Trials must be available for inspection by domestic and international regulatory authorities.

This is just a quick rundown of the guidelines of GCP and what they could mean for a clinical trial. This information, however, is not everything that a good clinical practice certificate offers. Delve deeper into the depths of ICH good clinical practice training!

GCP certification

There are a multitude of qualifications and knowledge a GCP certificate offers, but before we get more into that, we must first see what makes you eligible for such a certification. 

Who can apply for GCP certification?

There are a couple of positions that GCP certification is meant for:

  • clinical research coordinators 
  • clinical research associates 
  • principal investigators
  • members of the sponsor team responsible for clinical trials

Generally speaking, there aren’t any requirements or professional degrees a candidate has to possess to qualify for the certification but having a background in a relevant field. Example fields would be pharmacy, molecular biology, biochemistry, or life sciences which can be helpful, but not mandatory. 

Experience in clinical research or a related field is highly beneficial. This experience helps contextualize the GCP guidelines and understand their application in real-world scenarios.

Training programs and courses available

There are a couple of different options to receive a GCP certification, but the best option remains an online course, given its flexibility and abundance of materials. A prominent option for an online training course is the Astra Nova GCP certificate. How can such a certificate be beneficial to the different roles in the clinical trial we just mentioned?

For example, GCP certification equips clinical research coordinators with knowledge of regulatory and ethical standards. The certificate enhances their ability to ensure compliance and manage trial activities effectively. This increases their credibility and can lead to career advancement.

Clinical research associates, on the other hand, benefit from GCP certification through improved monitoring skills and ensuring trials are conducted according to GCP standards. This certification is often essential for career progression in clinical research organizations and pharmaceutical companies.

For principal investigators, GCP certification underscores their commitment to ethical research practices and participant safety, enhancing their ability to lead clinical trials and fostering trust with regulatory authorities and sponsors.

What to expect and how to prepare?

The GCP certification exam in the Astra Nova course is a test you can take after the four-hour-long course that covers five main topics:

  • the principles of the ICH GCP guidelines
  • responsibilities of clinical trial stakeholders
  • ethical considerations
  • essential documentation
  • management of clinical trials

There are a couple of ways to prepare for the examination. The first one is to utilize the official ICH GCP guidelines and course materials provided during training.

The last thing you should know about the exam is that the format can vary depending on the certifying body but usually includes multiple-choice questions. 

What knowledge does the certificate offer?

There are a couple of basic but still key components a certification course may offer::

1. Institutional Review Boards (IRBs)

Institutional Review Boards (IRBs), also known as independent ethics committees, are groups responsible for reviewing and approving clinical trials involving human participants. The main function of an IRB is to ensure the safety and rights of the participants.

Furthermore, review boards have the responsibility to evaluate research protocols and related materials (e.g., informed consent documents and study plans) to ensure they are ethical and comply with regulatory requirements. They must also monitor ongoing studies and review proposed changes to protocols. 

2. Investigators

Investigators are individuals, usually doctors, scientists, or researchers, responsible for conducting a clinical trial. They play a critical role in the day-to-day management of the study by ensuring the integrity of the data collected, and the welfare of the study participants.

One of the chief functions of investigators is to ensure the study is conducted according to the investigator’s brochure, approved protocol, and GCP guidelines. They must also obtain and document informed consent from each study participant. An important aspect of their job is to report adverse events and ensure continuous medical monitoring throughout the study as well.

3. Sponsors

A sponsor is an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial.

Their responsibilities include the selection of qualified investigators as well as providing them with the necessary information to conduct the trial. They must ensure the provision of all required study supplies and resources. Additionally, an investigator monitors the progress of the clinical trial and ensures that it is conducted and recorded according to the protocols, GCP, and standard operating procedures. Sponsors are also a part of the positions that make sure that the participant’s rights are protected. 

4. GCP audit

A GCP audit is a systematic and independent examination of all clinical trial activities and documents to determine whether the activities were conducted and whether the data collected are according to the protocol, GCP, and the applicable regulatory requirements.

Usually, such audits are conducted by sponsors or regulatory authorities to preempt regulatory inspection by identifying areas of concern. The process includes four main aspects:

  • reviewing regulatory submissions
  • informed consent procedures
  • data handling and storage
  • the performance of trial personnel

Audits are also meant to ensure public trust in the credibility of clinical trial data and findings.

5. Clinical trial protocol

A clinical trial protocol is a document that describes the objectives, design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial.

There are many things in protocol details. One of them is not only to set the objectives and purpose but to create the design of the entire process. Such protocols list criteria for the selection of participants as well as the exclusion. Furthermore, they determine the frequency of treatment administration and the duration of the entire study.

6. Investigator’s brochure

The Investigator’s Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational products that are relevant to the study of the product in human subjects.

This brochure is a lot like the clinical protocol but has more to deal with the specifics of the pharmaceutical product than the trial itself. This brochure includes a description of the drug substance and formulation. It also shows a summary of findings from nonclinical studies and an overview of human clinical trial data. The other aspect of it also has to deal with potential side effects and risks associated with the product.


Exploring career opportunities in Big Pharma

As we have mentioned, having a GCP certificate can be greatly beneficial to future career prospects in the pharmaceutical industry. But what potential roles can you take with a certain educational background? Let’s take a look!

Molecular biology

A student with a background in molecular biology and a GCP certificate is well-equipped to become a Clinical Research Associate (CRA). This role involves three main functions:

  • monitoring the progress of clinical trials 
  • ensuring compliance with regulatory requirements
  • verifying that the data collected is accurate, complete, and verifiable from source documents

The deep understanding of biological processes and genetic data that comes with a molecular biology background is highly beneficial in trials that involve genetic testing or targeted therapies. Paired with the enhanced credibility and recognition in the professional community, the understanding of complex biological systems and the ability to interpret genetic data are what make a molecular biology graduate perfect for such a position. 


Graduates in biochemistry who also hold a GCP certificate could excel as Clinical Data Managers. The collection and coordination of data as well as its analyses are the main focus of this role. Biochemists’ strong foundation in chemical and biological processes enables them to understand and manage the biochemical markers and pharmacokinetics involved in trials effectively. They ensure the accuracy and integrity of clinical trial data, which is crucial for the success of the trials.

Possessing formal GCP training offers such graduates improved job prospects and career advancement opportunities in clinical research. Their analytical skills and knowledge of biochemical interactions within the body make them ideal candidates.


Pharmacy graduates with a GCP certificate are well-positioned to be clinical trial managers. This role involves overseeing the development and implementation of clinical trials, ensuring they are conducted according to all the regulations and protocols. Their pharmaceutical knowledge is crucial for understanding the therapeutic effects and potential side effects of the medications being tested in trials.

What makes pharmacy graduates ideal candidates for such a position is their extensive knowledge of drug interactions, effects, dosage forms, and compliance with regulatory standards. 

Having an education in prominent medical fields is an amazing start to a future in the industry. Combining such an education with a GCP certificate can open even more doors to your desired career path. 

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