clinical trial Archives | Page 4 of 9

Aug28 0

Cost and time for clinical development constitute more than 70% of the total development of any drug! Small – mid-scale biopharma are known for their innovative approaches, agility, and faster developments. However, clinical development has always been one step too important, yet too hard for them. There are ways to overcome these challenges and optimize […]

Aug16 0

Most of the small and mid-size pharma are stressed out while outsourcing pre-clinical and clinical development to CRO (Contract Research Organization). Selection factors differ while choosing CRO for large and small-medium scale companies. These include factors like budgeting, multiple region selection, and approaches. Increased outsourcing is seen in pharmaceutical and biotechnology companies, with 85 percent of […]

Aug16 0

Patient recruitment in rare disease clinical trials presents several difficulties. These challenges include limited eligible patients, dispersed geographic distribution, low disease awareness, site and investigator identification difficulties, and ethical considerations. They hinder participant enrollment and cause trial completion delays. Over the past few years, the rate of drug development in rare diseases has been increasing. […]

Jun15 1

Revised Chinese regulations that brought a lot of changes in clinical trials and product registrations were received with lots of questions. If you have got questions that are yet unanswered, you are not alone. Many researchers, developers, and managers are not sure about one aspect or another on how to comprehend, act, or change their […]

May31 2

Do you know any product segment where one does not get to encounter Chinese products? Well, hardly any. It has been the focus of the Chinese government for the past several decades to dominate various industrial sectors, including pharmaceuticals. While China has been the big production factory for generic drugs and API ingredients for many […]

May15 0

The development of drugs in rare diseases provides great opportunities to pharma companies along with challenges that are required to overcome during drug discovery, pre-clinical, and clinical stages of drug development. Commercially rare diseases drug development differs from traditional diseases, as there are considerably few patients to take the drug, therefore pharmaceutical companies should consider […]

Mar27 2

Thailand FDA periodically releases a list of institutional review boards (IRBs) / ethics committees (ECs) that it recognizes for acceptance of clinical trials. Under Thailand’s regulatory system, approved ethics committees serve as the main point of approval for initiating clinical trials in the country. It has been explained in our previous articles (see Part I […]

Mar14 0

Brazil has grown exponentially in clinical research over the last decade. During the past 3 years, clinical trials in Brazil have grown significantly, with the country becoming one of the three most dominant emerging countries, along with India and Russia, which together attract the highest number of Western companies outsourcing clinical trials. Brazil is a […]

Feb28 0

A case record form (CRF) is a great and necessary tool used in clinical trials to collect data from each participating patient. CRF (also referred to as case report form) has historically been on paper (unlike electronic ones these days). Traditionally, something like carbon copy paper, where the sponsor can utilize one sheet for the Trial Master […]

Feb15 3

Over a million people are currently living with TB in Indonesia, making up more than 10% of the world’s TB burden. Of the estimated 32 000 new cases of drug-resistant TB in the country, only about a third of these cases were detected. In a country with a high malaria burden, less than 1% of […]

Tag: clinical trial

How can small-mid scale bio-pharma fast track their clinical development & product registration processes? Leveraging secrets of a global network

How To Choose a CRO?: Small and Mid-Size Pharma Companies

Rare Diseases: Patient Recruitment Strategies in Clinical Trials

What would you ask China FDA officials that can improve your clinical trials and product registrations experience in China?

Clinical Trial Requirements and Practical Scenario for Marketing Approval in China

Rare Diseases: Pre-Clinical Studies And Clinical Trials In Orphan Drug Development

Thailand Latest Approved IRB List: Update 2

Clinical Trial Regulatory Process – Brazil

What is the best EDC system / eCRF you’ve ever used? Review of online user-initiated surveys on social media

Clinical Trials In Indonesia