Research is a very important segment of pharmaceutical business. It ensures growth and stability of business through its support to explore the market opportunities, to initiate timely actions and to sustain the delivery and communication of meaningful differentiation to all business stakeholders. Pharmaceutical research has 2 entirely different interfaces which are mutually interconnected at their backend. 1st is the Clinical Research which has the capability to positively change the business scenario; if conducted scientifically with an appropriate methodology, presented at a reputed forum, published in a reputed journal and subsequently used effectively by the marketing department. On the other hand Market Research is the tool which is not only the prerequisite of a well thought clinical research but also plays a vital role in strategic decision making.
Holistic Research Solutions (H.R.S) made it possible to conduct required research even to those pharmaceutical companies which cannot afford to establish their own research departments.
1. What is clinical research?
Clinical research is a branch of healthcare science that determines the safety and effectiveness treatment regimens intended for human use. It may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical Research is different from clinical practice. In clinical practice one uses established treatments, while in clinical research evidence is collected to establish a treatment.
2. What are different phases of clinical research?
Clinical trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV are 'post-approval' studies. Before pharmaceutical companies start clinical trials on a drug, they conduct extensive pre-clinical studies.
3. What is meant by pre-clinical studies?
In drug development process, pre clinical studies which are also known as non clinical studies are basically the steps of clinical research prior to drug trials in human beings. These are initially carried out in laboratories and then tested on animals. Feasibility, iteration (repeating the process again & again) and drug safety data collection are important steps of pre-clinical studies.
4. What are the types of clinical trials?
Generally there are different classification models to differentiate different types of clinical trials. We will discuss here only one model which is based on the objective of the researcher where he starts the trial either with an objective of treatment or just with his observations. Hence there are two types of clinical trials, observational and treatment based.
5. What are different designs of clinical research?
Observational studies may be designed as cohort, case control, cross sectional, or ecological whereas treatment based trials can either be designed as randomized or adaptive. (all details are available in our section of ‘Research Resource Support’
6. Is there any ethical concern while conducting a clinical research?
Yes there are major concerns which are mandatory to be addressed while conducting a clinical research. Clinical research ethics are the set of relevant ethics considered in the conduct of a clinical trial in the field of clinical research. It borrows from the broader fields of research ethics and medical ethics. Various organizations have created guidelines for it which we have shared in the segment of ‘Research Resource Support’
7. Which phase, type and design of research is recommended to be initiated in Pakistan?
We wish every type, design and phase research in Pakistan but we can support phase III & IV trials of all types and designs.
8. What is its scope in Pakistan?
It has two dimensions. On one hand it is the responsibility of growing pharmaceutical industry of Pakistan to come up with research work and on the other hand it is a big opportunity as it is relatively uncommon so can give a big competitive advantage if carried out professionally.
9. Which type of infrastructure is required by a pharmaceutical company to initiate a clinical research project?
As it is not a lab based study so pharmaceutical companies do not need to establish an infrastructure for it. These used to be carried out in tertiary care hospitals where its proposal, protocols, methodology and analytical work will be carried out by the team of professionals at Holistic Research Solutions.
10. What are the benefits for a corporate by doing clinical research?
Clinical research is a magical tool for the growth of pharmaceutical business. Short term growth is usually seen by the institutions where the research is going on due to the repetitive message of the brand as well as improved brand image in front of clinicians of that institution. Long term growth is seen after completion of the research work when it is presented at any reputed forum, or published in a reputed journal and through its subsequent effective use by the marketing department. This long term benefit can upgrade the brand even at the position of brand leader.
11. What is the guarantee that the results of this research will be in favor of our product?
You can find its guarantee only by your quality assurance and quality control departments.
12. Does Holistic Research Solutions (H.R.S) has the capability to get its research presented and published nationally and internationally?
Of course we have a team of experienced professionals who have their post graduate studies in respective departments, experience of respective segments nationally and internationally. If you abide by the protocols given to you for the research work, we can ensure you that as far as the research parameters are concerned, our research work will be comparable to any of the research institution of the world.
1. What is Market Research?
Market research is the most important strategic tool advised to be used minimize not only the cost of production but also the cost of operations and cost of sales. It also works to maximize the revenue of the organization through identifying and rectifying the target customers as per their potential and business behavior. Collectively these two parameters (cost minimization and revenue maximization) ensure the best profitability to the corporate.
2. What are the types of market research?
These are broadly categorized into two segments; primary and secondary research. Primary research is new research, carried out to answer specific issues or questions. It can involve questionnaires, surveys or interviews with individuals or small groups. Whereas Secondary research makes use of information previously researched for other purposes and or for the same purpose by some other professionals who do it for commercial purposes. In pharmaceutical industry secondary research work is prepared by IMS and Sals. These are two professional bodies who offer their primary research to the pharmaceutical industry to be used as secondary research. They have a commercial price for their service.
3. What are the benefits of market research to corporate?
The ultimate benefit to a corporate is the profit maximization. It is either through cost cutting or through revenue building. Cost cutting is possible through benchmarking in segments of productions, operations and sales management whereas revenue maximization is possible by objective oriented study of customers and competitors.
4. Is every decision is needed to be finalized after market research?
Everyone cannot go for market research for every decision. It is needed in strategic decisions. It is neither cost effective nor time effective to go for research in tactical research. Tactical decisions are needed to be based on a combination of intuition, judgment and past experiences.
5. Is it not appropriate to go with intuition, judgment and past experiences for strategic decisions?
We usually don’t recommend it. Strategic facts about market are more or less like a country and experience of a single person is exactly like the exposure of a single person to that country. Even with the biggest exposure of a single person, there are ample chances of misunderstanding of a geography, demography or psychography of any or many areas; the same can happen with intuitive and judgmental decision making in strategic issues. These are needed do be dealt with scientifically through market research.
6. What are the functional differences of primary and secondary market research?
Secondary research is used for extensive models where larger sample base is required to be evaluated for small number of parameters whereas primary research is needed where detailed feedback or large number of parameters is mandatory to be evaluated with a smaller sample base. Another important point is that the primary research is carried out where reliable secondary data is not available.
7. What are the tools of secondary research in pharmaceutical industry?
IMS and Sals are commercially available as powerful tools of secondary research in pharmaceutical industry.
8. Is there any work up needed after purchase of secondary research data?
Of course, interpretation of secondary data is very important, and this interpretations is based on some arithmetical and statistical evaluation. Currently these tools are being used by a number of companies successfully as ‘research tool’ for profit maximization whereas some other companies are using just as a symbol of respect and a ‘tool for meeting discussion’. Hence its arithmetical and statistical evaluations is mandatory to have its benefit as a ‘research tool’.
9. What is the significance of primary research in pharmaceutical industry?
It helps in multiple segments but especially in brand positioning and customer targeting.
10. What are the subtypes of primary research?
Subtypes of primary research are qualitative and quantitative research.
11. What is research outsourcing?
Research outsourcing means not to hire the research professional on corporate payroll, rather than to get involved with professional researchers who can support the corporate right from objective formulation till the analysis of data, interpretation of results and conclusion for the action.
12. Is research outsourcing advisable for every type and every segment of market research?
No, it is adviseable only in cases where either the cost of hiring a professional team is expensive than getting it done from outside professionals; or where the quality of research is compromised by the in-house team members.
Research Resource Support